Jobs

Geef uw doelstellingen aan help uw loopbaan sneller vooruit.

Operaties en Supply Chain

5 resultaten

Maintenance and Test Engineer - Medical Device - Awans

Miracor Medical is a class IIb/III medical device company specialized in improving clinical outcome of patients with impaired cardiac function, active in interventional cardiology. The company has developed a high potential proprietary technology that consists of hardware, software and catheter(s).

The technology is in advanced clinical stages, with various potential therapeutic applications (among others acute infarct and heart failure). More than 190 patients have been treated with the recent version of the technology. The company aims at getting CE Mark and approval from FDA to run a pivotal study in the next 2 years. 

Miracor Medical’s offices are based in Awans, Belgium. The company is now looking for talented and enthusiastic talents to expand its international team. For additional information about the company and its technology, please visit www.miracormedical.com.

Miracor Medical offers a culturally diverse English speaking working environment in the heart of Europe, Belgium, a few hours away from Europe’s capital cities.

To support the development of the company, we are looking for a (m/f):

Maintenance and Test Engineer

Responsibilities:

Reporting to the R&D Director, you support all maintenance and test activities and ensure that processes, procedures and controls are adapted to the operational needs. Your main responsibilities are:

  • You organize and perform the service and maintenance of consoles.
  • You create and enhance cases and perform verification tests.
  • You manage and calibrate test equipment.
  • You conduct first article inspections.
  • You generate and review quality and technical related documents.
  • You report results and work evolution on a regular basis to your line manager.
Profile:
  • Hands-on experience with electronics, mechanics and/or mechatronics. Experience in the Medical Device industry or in another highly regulated industry is a plus.
  • Strong communication skills together with hands-on and pragmatic mind-set.
  • Very good organizational, analytical and problem-solving skills.
  • Ability to work in a fast-paced, highly integrated team environment where accuracy, accountability quality, safety and timeliness are essential.
  • Highly collaborative, self-motivated and team-oriented individual in a company setting.
  • Good oral and written communication skills in English. Any other language is a plus.
Offer:
  • A challenging and diversified position within a high-potential innovative medical device company.
  • To work in a human size, dynamic, respectful and professional environment.
  • An attractive compensation package in line with the position responsibilities and your experience.

Head of CMC - Bio-Pharma/Biotech - Liège

ASIT Biotech is a Belgian clinical-stage biotech company focused on the development of breakthrough immunotherapy products for the treatment of allergies.

Thanks to its innovative technology platform, ASIT Biotech currently holds a leading and unique position on the market. This innovation results in a short treatment, expected to improve patient compliance and quality of life. ASIT Biotech’s product pipeline targets to significantly expand the current immunotherapy market. For more information about the company, please visit www.asitbiotech.com.

With a headcount of 25 staff members, ASIT Biotech is located in Liège, Belgium. In order to support its high-potential developments, we are looking for a (m/f):

Head of CMC

Responsibilities :

As Head of CMC, you are responsible for all CMC-related technical operations activities, including overall management of process and product development, selection and oversight of the pharmaceutical supply chain, technology transfer, manufacturing and supply of clinical trial material. You ensure the Quality and RA compliance of CMC-related activities with the corporate policies.

You report directly to the CEO and are part of the Executive management.

Your main responsibilities include:

  • Lead the overall management of product and process development.
  • Manage all drug substance and drug product activities from technology transfer to clinical supplies for clinical studies.
  • Identify, select and manage CMOs for process optimization, cGMP manufacture, supply, testing, release and distribution of Drug Substance (API) and Drug Product (DP).
  • Manage the non-GMP productions and associated analytical development activities.
  • Deliver robust, scalable and cost-effective manufacturing routes.
  • Implement appropriate analytical methods and protocols in coordination with QA.
  • Ensure the compliance of all CMO with relevant regulatory standards.
  • Define and execute plans for API and DP validation and registration, in coordination with QA and RA.
Profile :
  • PhD in Life Science with at least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment.
  • Relevant expertise in lab techniques focused on protein expression, isolation and analysis.
  • Strong experience in managing CMOs for the manufacture of cGMP APIs and DP.
  • Experienced in cGMP manufacturing and IND, CTA and NDA regulatory filings.
  • Thorough knowledge of relevant FDA and EMEA regulations.
  • Experience with implementing technical, strategic and operational plans.
  • Excellent communication and organizational skills.
  • Ability to identify and resolve critical issues.
  • Fluency in French and English.
Offer :
  • A challenging leading position within a stimulating and dynamic work environment.
  • A variety of interesting contacts with international exposure.
  • The opportunity to have direct impact on the results of a high-potential biotech company.
  • An attractive compensation package in line with the position responsibilities and your experience.

Operations Manager– Microbial Therapeutics - Biotechnology - Brabant wallon

A-mansia is a biotech company focusing on microbiome therapeutics addressing human health issues like obesity and related disorders. The mission of A-mansiais to provide innovative solutions based on Microbiome Therapeutics.

Under the implementation plan in the Walloon Brabant province and its future development, A-Mansia is searching for a dynamic and enthusiastic person to strengthen the team. For more information about the company and the technology, please contact us via recruitment@pahrtners.be.

A-Mansia offers a French, Dutch and English-speaking environment, culturally diversified and located in the heart of Europe, in Belgium, few hours from European Capitals.

To strengthen the team in Mont-Saint-Guibert, we’re looking for an (m/f):

Operations Manager– Microbial Therapeutics

Main responsibilities:

Reporting directly to the CTO, you are in charge of the whole production management for the fermentation process starting from sourcing of raw materials to commercialisation of finished products. You are the point of contact with the CMO(s) in charge of the finished products’ outsourced manufacturing of microbial products.

Your main tasks are:

  • Lead production projects and product launch on the market: sourcing of raw materials with the CMO, logistic, galenic development & packaging.
  • Coordinate the whole outsourced production and supply chain.
  • Define specifications, negotiate contracts and manage the collaboration with the CMOs and third parties.
  • Verify the raw materials’ compliance and control outsourced performances.
  • Control and lead the Cog’s at the product launch and on a long-term basis.
  • Be in charge of the internal supply chain team.
  • Report appropriately the progress of undertaken steps in an adapted manner.
Profile:
  • You hold a Ph.D. or you are engineer in Nutrition or Life Sciences, or equivalent by experience.
  • You have at least 5 years of industrial experience in production management related to the production of probiotics/ food complements.
  • You have experience and knowledge in fermentation process(es).
  • You have hands on experience in or knowledge of managing CMO’s and third parties.
  • You have skills in managing projects about launching food complements on the market.
  • You take advantages of an extended network on the industrial level and strong leadership.
  • You are rigorous, flexible, hands-on, independent, dynamic and pro-active.
  • You are fluent in English. The command of French and/or Dutch is an asset.
Offer:
  • A diversified position within a young and growing start-up.
  • A key position for the development of the company.
  • The opportunity to join a human sized, dynamic and professional environment.
  • A permanent employment contract.
  • An attractive compensation package in line with your experience.

Senior Operations Manager – Radio-Pharma - Radio–Pharma - Fleurus

Situées à Fleurus (Belgique), l’IRE et sa filiale IRE ELiT sont des entreprises industrielles renommées et innovantes.

Avec plus de 185 collaborateurs, l’IRE est un des principaux producteurs mondiaux de radio-isotopes utilisés en médecine nucléaire à des fins de diagnostic et de thérapie. IRE ELiT est active dans la protection de l’environnement et dans la production radio-pharmaceutique.

Ces entreprises contribuent à la santé de millions de patients dans le monde chaque année. Sur les 5 dernières années, l’entreprise a renforcé son développement et jouit d’une croissance continue. Veuillez consulter www.ire.eu.

Pour assurer le bon développement de l’IRE ELiT, nous sommes activement à la recherche d’un (m/f) :

Senior Operations Manager – Radio-Pharma

Responsabilités :

Rapportant à la direction générale, vous avez la responsabilité de la partie industrielle de l’IRE-ELiT. Vous implémentez la stratégie de l’entreprise : vous coordonnez les opérations de production, d’entreposage, d’approvisionnement et de distribution des produits, tout en veillant au respect des normes de qualité. Le plan d’affaire de la société prévoyant une importante croissance dans les années à venir, vous aurez la responsabilité d’assurer la capacité industrielle suffisante de telle sorte que l’approvisionnement du marché soit garanti en quantité, délais et qualité.

Les responsabilités suivantes vous sont confiées :

  • Coordonner et optimiser le fonctionnement de la production radio-pharmaceutique.
  • Diriger, motiver et développer les collaborateurs de l’équipe.
  • Mettre en œuvre la stratégie de l’entreprise au sein des opérations.
  • Veiller au respect des normes de qualité dans un environnement GMP de production de médicaments stériles injectables, et au respect des normes environnementales et de sécurité.
  • Mettre en œuvre une politique d’amélioration continue et d’optimisation des investissements.
  • Planifier et contrôler l’évolution du budget, accompagné par le département financier.
  • Interagir, en tant que principal point de contact, avec les institutions externes.
  • Rapporter de manière structurée, rigoureuse et adaptée les résultats des activités.
Profil :
  • Vous êtes titulaire d’un Master en Pharmacie, Chimie, Biotechnologie, Ingénieur ou équivalent.
  • Vous disposez de minimum 10 années d’expérience dans une fonction comparable au sein d’un environnement GMP.
  • Vous avez, par votre expérience ou vos formations antérieures, un intérêt marqué et des connaissances de bases généralistes en business management (finance, marketing, stratégie, gestion des opérations…).
  • Vous démontrez de l’aisance dans la gestion d’équipe et de projets.
  • Vous communiquez efficacement, avec assertivité, et possédez une certaine aisance relationnelle.
  • Vous possédez une bonne connaissance du français et de l’anglais.
  • Vous êtes polyvalent, autonome, organisé et rigoureux.
  • La connaissance des outils du LEAN Manufacturing est un sérieux atout.
Offre :
  • Une fonction stimulante et diversifiée incluant des responsabilités et des projets intéressants.
  • Des défis professionnels, financiers et humains stimulants et enrichissants.
  • Des contacts variés avec des acteurs majeurs de l’industrie.
  • L’opportunité de renforcer une structure industrielle renommée, innovante et en forte croissance.
  • Un salaire attractif reprenant des avantages extra-légaux, en phase avec votre expérience.

Program Management Officer - Biotechnology - Gosselies

Located in Gosselies (Belgium), MaSTherCell is a service company (CDMO) in biotechnology. MaSTherCell is specialized in production outsourcing, process development and quality management (QA/QC/QP) for cell therapy.

With around 110 employees, MaSTherCell supports its customers (big pharma, biotech, etc.) in the development and production of innovative medicines. MaSTherCell actively contributes to improving the quality of life and health of many patients. For more information, please visit http://www.masthercell.com.

To support MaSTherCell in its strong growth, we are actively looking for a (m/f):

Program Management Officer

Responsibilities:

Reporting to the Executive committee, you assist them in selecting and planning strategic internal projects/programs (including new sites integration), and in reporting on their progress.

Your main responsibilities are:

  • You implement project management tools, project control processes, procedures and policies.
  • You monitor and control the internal program/project throughout their entire lifecycle.
  • You select program/project and you argue program/project closedown if necessary.
  • You assess the relative priority of internal projects and programs.
  • You set up performance reporting and program/project governance for customer and internal projects.
  • You lead the project financial tracking with the business controller.
  • You provide support to project teams and task planning.
  • You report your work on a regular basis.
Profile:
  • Master’s degree in Engineering, Life Sciences or any related field.
  • Minimum 3 years experience in project management in the pharmaceutical industry and/or in a consulting services company.
  • A project management professional certification is an asset.
  • Strong communication skills together with hands-on and pragmatic mind-set.
  • Very good organizational, analytical and problem-solving skills.
  • Highly collaborative, self-motivated and team-oriented individual in a company setting.
  • Good oral and written communication skills in English. Any other language is a plus.
  • Computer skills:  Microsoft office, Digital document management system and Project management IT tools.
Offer:
  • A challenging and diversified position within a high-potential innovative biotech company.
  • To work in a human size, dynamic, respectful and professional environment.
  • A variety of interesting contacts with international exposure.
  • An attractive compensation package in line with the position responsibilities and your experience.

Andere loopbaanmogelijkheden

34 resultaten

Product Specialist - Medical Device - Liège

Headquartered in Liège, Dim3 develops and markets innovative eHealth software and devices in the area of Clinical nutrition to facilitate medical decisions and enhance the life of patients.

Dim3’s technologies bring a great knowledge of healthcare and clinical biometry together with disruptive 3D scanning and software engineering experience. Dim3’s clinical nutrition management tools and connected products integrate automatic medical data collection, interpretation and visualization to give healthcare professionals clear and objective information in real-time.

For more information, please visit: www.dim3.com

In order to support Dim3’s development, we are actively looking for a (m/f):

Product Specialist

Responsibilities:

As a Product Specialist, you guide Dim3’s products to even higher levels. You have a key role in the team. You deal with medical practitioners, customers and partners in order to determine the future direction of Dim3’s applications including specific features, functionality and business models. You deeply understand the pains patients feel and invent ways to translate their needs into smart software.

Reporting to the CTO, you work in close cooperation with customers, the Management Team, Product Development, Clinical Affairs and Sales. Your main responsibilities are:

  • You initiate the product roadmap and strategy in line with market needs and business priorities.
  • You define the pricing strategy and constantly analyze market trends and competitors’ evolution.
  • You support the Sales team in analyzing customers project requirements, in defining adapted technical solutions, and in developing written and oral commercial proposals.
  • You define new products specifications or improvements in an efficient way.
  • You manage the release process in collaboration with the other departments.
  • You develop adapted local marketing tools and actions.
  • You report work evolution on a regular basis.
Profile:
  • Master’s degree in Business, Engineering or equivalent through experience.
  • 5 years of experience in a Product Management position with technical products. Experience in medical software and/or devices is a plus. Experience in nutrition is also an asset.
  • Results and customer oriented, rigorous, autonomous and flexible.
  • Analytical, organized, team player, open-minded with a start-up mind-set.
  • Fluent in French and in English. The command of any other language is an asset.
  • Strong oral and written communication.
  • Willing to travel for short periods (20% of your time) on a regular basis.
Offer:
  • A challenging position with direct impact on patients’ health and quality of life.
  • The opportunity to jump into an innovative medical software engineering company, a fast-growing start-up environment where teamwork, results and patient care are very important.
  • Varied contacts with professionals on an international scale.
  • Significant learning and evolution opportunities.
  • An attractive salary package.

Assistant Commercial - Belgian Brewery - Péruwelz

La Brasserie Caulier est une entreprise familiale de la région de Tournai, située à Péruwelz. La brasserie produit ses propres bières depuis près de 20 ans et jouit d’une excellente réputation dans le secteur.

L’équipe actuelle, composée de 16 passionnés, brasse des bières 100% naturelles, appliquant des méthodes de fabrication artisanales.

Afin de soutenir la croissance de la Brasserie Caulier, nous sommes à la recherche d’un (h/f) :

Assistant Commercial – Customer Satisfaction Manager

Responsabilités :

En étroite collaboration avec le département logistique, comptable et l’équipe commerciale, votre mission principale est de garantir la satisfaction des clients. En ce sens, vous assurez le suivi des ventes et êtes le premier contact du client avec la Brasserie Caulier.

Vos responsabilités seront les suivantes :

  • Assurer l’accueil téléphonique des clients, l’accueil de la brasserie et d’éventuelles visites de brasserie.
  • Traiter les commandes des clients et effectuer le suivi de la facturation des ventes.
  • Mettre en place le reporting commercial, sortir les statistiques de ventes périodiques par produit et par marché.
  • Organiser et suivre les plannings promotionnels.
  • Participer à l’organisation d’événements orientés client (ex: portes ouvertes) et de salons commerciaux.
  • Organiser et assister aux réunions commerciales pour en assurer leur efficacité.
  • Assister les démarches commerciales de terrain en étant le relais au sein de la brasserie.
Profil :
  • Vous êtes passionné(e) par le monde brassicole.
  • Vous démontrez d’excellentes aptitudes communicationnelles et relationnelles.
  • Vous parlez couramment le français et pouvez vous exprimer aisément en Néerlandais et en Anglais.
  • Vous êtes reconnu(e) pour votre rigueur, votre autonomie, votre sens du service, votre diplomatie et vos compétences organisationnelles.
  • Vous maîtrisez la suite Microsoft Office. Une expérience avec un ERP/CRM constitue un atout.
Offre :
  • Une fonction diversifiée au sein d’une entreprise familiale et conviviale.
  • Des possibilités de formations, de développement et d’évolution de carrière.
  • Un contrat à temps plein et à durée indéterminée, assorti d’un package salarial adapté à votre profil, à votre niveau d’expérience et au contexte.

Ingénieur Commercial Grands Comptes - Energie - Paris

Dunkerque LNG est en charge de l’exploitation et de la commercialisation du terminal méthanier de Dunkerque, deuxième plus grand terminal méthanier d’Europe continentale.

Fort d’un chiffre d’affaire annuel de 190€ millions, Dunkerque LNG est un atout majeur dans le développement de la stratégie d’approvisionnement en gaz du groupe EDF en raison de son raccordement unique à deux marchés de consommation : la France et la Belgique.

La société est composée d’une vingtaine de collaborateurs répartis sur les sites de Dunkerque et de Paris La Défense.

Afin de renforcer l’équipe commerciale de Dunkerque LNG à Paris, nous sommes activement à la recherche d’un (h/f) :

Ingénieur Commercial Grands Comptes

Responsabilités :

En tant qu’Ingénieur Commercial Grands Comptes, vous participez activement au développement du terminal tant d’un point de vue commercial qu’opérationnel. Rapportant au Directeur Commercial, vous êtes responsable de la relation commerciale avec les clients et les différents partenaires de Dunkerque LNG.

Vos principales responsabilités sont les suivantes :

  • Entretenir et développer la relation commerciale avec les clients de Dunkerque LNG, EDF et Total.
  • Veiller au respect des contrats de réservation de capacité et de leur mise en œuvre opérationnelle.
  • Supporter la Direction Commerciale dans le pilotage de la relation contractuelle et/ou opérationnelle des prestataires : suivi du contrat de service, lancement et réception de nouveaux développements, etc.
  • Prospecter de nouveaux clients, notamment en participant à différents forums et salons industriels.
  • Planifier et gérer l’activité du terminal : bateaux, émission, stock, etc.
  • Rapporter de manière régulière la performance commerciale et opérationnelle du terminal.
  • Participer aux astreintes de soutien à raison d’une semaine sur quatre.
Profil :
  • Vous êtes titulaire d’un Bac+5 de type école de commerce, d’ingénieur ou universitaire.
  • Vous disposez de 10 ans d’expérience dans une fonction commerciale dans le secteur gazier.
  • Vous êtes orienté(e) clientèle, résultats et solutions, et doté(e) d’un très bon relationnel.
  • Vous êtes flexible, autonome, organisé(e), analytique et rigoureux(se).
  • Vous communiquez aisément en Français et en Anglais.
  • Vous êtes basé(e) à Paris La Défense et disposé(e) à vous déplacer de manière régulière à Dunkerque et ponctuellement à travers le monde.
Offre :
  • Une fonction stimulante au sein d’un environnement diversifié.
  • L’opportunité de rejoindre un acteur majeur dans l’industrie du gaz en Europe.
  • Des challenges et des contacts variés au sein et en dehors de l’organisation.
  • Des opportunités de développement et de formations.
  • Un salaire attractif reprenant des avantages extra-légaux avantageux.

Flow Cytometry Specialist - Bio-Pharma/Biotech - Gosselies

Caprion Biosciences, a contract research organisation with facilities in Montreal (Canada) and Gosselies (Belgium), offers analytical services to biopharmaceutical companies for the characterization of the human immune response in pre-clinical and clinical samples.

Caprion operates globally, with partners in North America, Europe and Asia, including large pharmaceutical companies and biotechs.

For its site in Gosselies and in the context of its growing immune monitoring service offering, Caprion is looking for a (m/f) :

Flow Cytometry Specialist

Responsibilities :

Reporting to the Laboratory Manager and working closely with Principal Scientists, the Flow Cytometry Specialist will work within a team focusing on the characterization of the immune response.

Tasks include :

  • Ensure that efficient and technically suitable cytometry systems and procedures are implemented in the laboratory, including instrument calibration and maintenance, flow cytometry-related SOP and forms, maintenance contracts, etc.;
  • Ensure that flow cytometer-related procedures are properly followed by the users;
  • Train, supervise and mentor laboratory personnel using the flow cytometry platform;
  • Prepare the flow cytometry settings and perform data acquisition as needed;
  • Support the Research Assistants for the troubleshooting of acquisitions;
  • Lead the on-site implementation of multisite procedures, QC, inter-equipment qualification and proficiency testing;
  • Act as a technical resource for the analysis of cytometry data;
  • Provide proposals for the design of complex antibody cocktails to the scientific team;
  • Write SOP and CSP as required;
  • Maintain instrument-related documentation as per GLP/GCLP and regulatory requirements and guidance;
  • Document and manage in a timely manner the instrument malfunctions and the deviations linked to cytometry operations;
  • Interact with vendors and field service engineers;
  • Participate in the preparation and conduct of client or regulatory body audits.
Profile :

The applicant must hold a master’s degree (or the equivalent) or a Ph.D. in a life science discipline such as biology, medical biology or biochemistry/biotechnology and a minimum of 4 years of recent and relevant cytometry experience.

The applicant must :

  • Demonstrate thorough knowledge of LSR and Fortessa cytometer voltage and compensation settings;
  • Be proficient with flow cytometry softwares such as Diva and FlowJo.;
  • Have a good knowledge of complex multiparametric panel design;
  • Demonstrate excellent organisational skills and ability to prioritize tasks;
  • Demonstrate schedule adaptability and flexibility;
  • Demonstrate excellent problem-solving skill;
  • Demonstrate ability to work in a multi-tasking and fast-paced environment;
  • Be willing to actively participate to the generation, the implementation and the continuous improvement of laboratory processes;
  • Demonstrate ability to work in a Quality environment (ISO17025, GCLP, GMP) and apply good documentation procedures (GDP);
  • Have a knowledge of flow cytometry proficiency programs;
  • Be functional in French (spoken and written) and have a functional knowledge of written English. Knowledge of spoken English is an asset.
Offer :
  • Full time permanent contract, with possibility of rapid start.
  • Diversified tasks and responsibilities and interesting projects.
  • A professional, dynamic and stimulating work environment.
  • Training and development opportunities.
  • A competitive salary package including benefits, adapted to your experience and the context.

Technical Advisor - Automotive - Brussels

Based in Brussels (Belgium), FIGIEFA is the European federation and political representative of the independent wholesalers and retailers of automotive replacement parts. Together with its 19 national European Member State members, it represents the interests of more than 30.000 companies trading with vehicle parts, components and accessories throughout Europe.

The aim of FIGIEFA is to safeguard a legislative environment in the EU that provides access to technical information, to the ‘connected vehicle’ and its in-vehicle data as well as to replacement parts/equipment as the basis for free and fair competition in the automotive aftermarket in a rapidly changing automotive technology environment.

In order to support the activities of its office in Brussels, we are currently looking for a (m/f):

Technical Advisor

Responsibilities:

As a Technical Advisor, you manage all technical and ‘connected vehicle’ IT-related dossiers and processes in connection with FIGIEFA’s activities in the area of the automotive aftermarket.

Your main responsibilities are:

  • Advise FIGIEFA in all technical and ‘connected vehicle’ IT-related matters.
  • Participate in meetings (in Brussels or EU) and take responsibility for the management of technical subjects and dossiers (e.g. telematics, EC type-approval legislation).
  • Support the FIGIEFA Secretariat in its information activities and meetings.
  • Advise and prepare answers on upcoming questions from the EU institutions and help in the preparation of position papers.
  • Liaise with FIGIEFA’s partner alliance AFCAR (Alliance for the Freedom of Car Repair in the EU).
  • Communicate with FIGIEFA legal/political experts and work out common strategies, statements, papers and positions.
  • Report results and work evolution on a regular basis.
Profile:
  • You are an experienced automotive technical expert or are experienced in vehicle-related IT technologies around the ‘connected vehicle’ (e.g. telematics and cybersecurity).
  • You are, preferably, specialised in vehicle communication, vehicle design/functionality, diagnostics or contemporary and developing vehicle technologies.
  • You have excellent oral and written communication skills in English and strong interpersonal skills.
  • You are flexible, proactive, and able to work on your own as well as in close cooperation with the FIGIEFA Secretariat.
  • You are able to assess the business consequences of new legislation, automotive technologies and vehicle related services.
  • You are ready to travel frequently to other European countries.
Offer:
  • A challenging position within a multi-national and political environment that tackles a wide range of technical issues.
  • The opportunity to support and promote free and fair competition in the automotive aftermarket and to safeguard a legislative environment at EU level.
  • Various contacts with European and international institutions while representing the interests of FIGIEFA members.
  • An attractive salary package in line with the position responsibilities and your experience.

Product Regulatory Affairs Specialist - Medical Device - Wavre

Founded in 2011, iSTAR Medical is a clinical-stage medical technology company that aims to provide leading patient care through the design, manufacturing and marketing of novel ophthalmic therapies.

iSTAR Medical develops innovative ophthalmic implants for patients with glaucoma. The ophthalmic implants are made from proprietary STAR® material, a technology from the University of Washington in Seattle (USA). For additional information about the company and the technology, please visit http://www.istarmed.com/

In order to support the development of the company, we are currently looking for a (m/f) :

Product Regulatory Affairs Specialist

Responsibilities:

As Product Regulatory Affairs Specialist, you are in charge of writing the technical documentation to support clinical study applications, CE marking and FDA registration. You insure compliance of product technical files with regulatory standards and provide support to ensure that regulatory standards are part of the Product Development Process.

Your main responsibilities are:

  • Write technical documentation including Investigator Brochures, Clinical Protocols, Product Risk Analysis, Biocompatibility Risk Assessments.
  • Prepare technical files for Clinical Studies filings, CE-Mark applications and FDA registrations.
  • Maintain technical documentation to ensure compliance with internal QMS and Regulatory Standards.
  • Support R&D and Manufacturing to define the product/process validation strategies in compliance with Regulatory Standards.
  • Ensure that normative and regulatory changes are identified in a proactive manner and coordinate actions plans.
  • Manage product registration processes.
  • Report work evolution on a regular basis.
Profile:
  • Master’s degree or Ph.D. degree in Science or equivalent through experience.
  • At least 5 years of experience supporting Regulatory Affairs for Medical Devices Class IIb.
  • Strong technical writing skills (Investigator Brochures, Clinical Study Protocols, Risk Management).
  • Good knowledge of Microsoft Office applications.
  • Excellent interpersonal, communication and presentation skills.
  • High level of attention to detail, excellent organizational skills and time management, flexibility.
  • Fluent in English, written and spoken. Knowledge of another language is an asset.
  • Willing to travel abroad occasionally.
Offer:
  • A full-time permanent position within a high-potential medical device company with direct impact on the lives of patients.
  • A professional, dynamic and stimulating work environment.
  • A variety of interesting contacts with international exposure.
  • An attractive compensation package in line with the position responsibilities and your experience.

Responsable Administratif et Financier - Belgian Brewery - Péruwelz

La Brasserie Caulier est une entreprise familiale de la région de Tournai, située à Péruwelz. La brasserie produit ses propres bières depuis près de 20 ans et jouit d’une excellente réputation dans le secteur.

L’équipe actuelle, composée de 17 passionnés, brasse des bières 100% naturelles, appliquant des méthodes de fabrication artisanales. La brasserie connaît une croissance importante depuis quelques années et vient d’entamer un vaste plan d’investissement qui lui permettra de doubler sa capacité de production.

Afin de soutenir la croissance de la Brasserie Caulier, nous sommes à la recherche d’un (h/f) :

Responsable Administratif et Financier

Responsabilités :

En tant que Responsable Administratif et Financier, vous faites partie de l’équipe de direction et êtes responsable des composantes administratives, financières et RH de la brasserie. Par votre intervention, vous facilitez la gestion opérationnelle de l’entreprise et la prise de décisions stratégiques.

Vous principales responsabilités sont les suivantes :

  • Mettre au point les budgets annuels avec le directeur général et veiller à leurs suivis.
  • Définir et mettre en place un système de contrôle de gestion efficace, notamment en améliorant l’implémentation et l’utilisation de Microsoft NAVISION.
  • Prendre en charge l’ensemble des démarches administratives, comptables et juridiques liées à la gestion de la brasserie.
  • Implémenter une gestion efficace des RH pour anticiper les besoins de l’organisation (recrutement, formations, politique salariale, établissement fiche de paie, etc.).
Profil :
  • Vous êtes titulaire d’un Master en économie, finance ou gestion.
  • Vous avez 5 années d’expérience, dont au moins 2 années en contrôle de gestion. Une expérience dans l’implémentation d’un ERP est un avantage.
  • Vous démontrez une passion pour la gestion d’entreprise et le monde brassicole.
  • Vous disposez de très grandes compétences analytiques et organisationnelles.
  • Vous démontrez d’excellentes aptitudes communicationnelles et relationnelles.
  • Vous travaillez aisément en équipe, et vous êtes force de persuasion.
  • Vous êtes reconnu(e) pour votre rigueur, votre autonomie, votre sens de la diplomatie et votre capacité à travailler par projet.
  • Vous êtes pragmatique, et orienté(e) résultats et solutions.
Offre :
  • Une fonction diversifiée comprenant de nombreuses responsabilités.
  • Des possibilités de formations, de développement et d’évolution de carrière.
  • L’opportunité de rejoindre une entreprise familiale et conviviale, et de contribuer à sa forte croissance.
  • Un contrat à temps plein et à durée indéterminée, assorti d’un package salarial adapté à votre profil, à votre niveau d’expérience et au contexte.

Senior R&D Manager - Medical Device - Awans

Miracor Medical is a class IIb/III medical device company specialized in improving clinical outcome of patients with impaired cardiac function, active in interventional cardiology. The company has developed a high potential proprietary technology that consists of hardware, software and catheter(s).

The technology is in advanced clinical stages, with various potential therapeutic applications (among others acute infarct and heart failure). More than 190 patients have been treated with the recent version of the technology. The company aims at getting CE Mark and approval from FDA to run a pivotal study in the next 2 years.

Miracor Medical’s offices are based in Awans, Belgium. The company is now looking for talented and enthusiastic talents to expand its international team. For additional information about the company and its technology, please visit www.miracormedical.com. 

Miracor Medical offers a culturally diverse English speaking working environment in the heart of Europe, Belgium, a few hours away from Europe’s capital cities.

To support the development of the company, we are looking for a (m/f):

Senior R&D Manager

Responsibilities:
  • You initiate and manage related projects.
  • You guide/manage risk management activities.
  • You create/review technical documentation and processes (as part of DHF, DMR, QMS).
  • You create verification and validation plans and coordinate their execution; apply statistical techniques in order to define samples sizes.
  • You organize and execute subjective evaluations (product reviews) to ensure all (product) requirements are met.
  • You review manufacturing documentation such as procedures/processes, BOMS and drawings.
  • You transfer and oversight of parts of manufacturing processes.
Profile:
  • Master’s degree in Engineering, Informational Systems or Computer Science.
  • 10+ years’ experience working in development of Class III (minimum IIb) medical devices (or other relevant regulated industry).
  • Ideally experience with hardware/software and catheters.
  • Experience in creating Risk Management plan, (Software) Hazard Analysis, DFMEA, PFMEA, Risk Management reporting.
  • Deep understanding of MDD (MDR), FDA 21 CFR 820, ISO13485 and ISO14971 standards
  • In-depth knowledge of the concepts of: design control, engineering change control, statistical techniques, verification and validation methods/protocols, design history files (DHF) and device history and master records (DHR/DMR).
  • Extensive understanding of statistical analysis, measurement and calibration systems, quality testing, sampling and inspection, process control, SOPs, etc.; Six Sigma certificate.
  • Excellent organisational and communication (oral and written) skills.
  • Ability to work on teams as well as individually.
  • Fluent in English (oral and written).
Offer:
  • A challenging and diversified position within a high-potential innovative medical device company.
  • To work in a human size, dynamic, respectful and professional environment.
  • International exposure, with learning and development opportunities.
  • An attractive compensation package in line with the position responsibilities and your experience.

Assistant(e) Administratif(ve) - Biotech - Strasbourg

Dynacure est une société de biotechnologies qui développe des traitements innovants pour les patients atteints de maladies rares sévères. Le premier programme de recherche de Dynacure se focalise sur les myopathies centronucléaires (CNM), des maladies dégénératives touchant les enfants et les jeunes adultes.

Fondée en 2016, Dynacure est une spin-off de l’IGBMC (Institute of Genetic and Molecular and Cellular Biology) de Strasbourg. Dynacure a établit une collaboration stratégique avec Ionis Pharmaceuticals (USA), un des leaders dans le domaine des sociétés de biotechnologies.

Dynacure déploie un plan de développement ambitieux et prévoit d’entrer en développements cliniques pour son programme en CNM en 2019. La société est basée à Strasbourg (Illkirch). Pour des informations complémentaires sur la société, veuillez visiter https://www.dynacure.com/

Afin de renforcer l’équipe de Dynacure, nous sommes activement à la recherche d’un (h/f) :

Assistant(e) Administratif(ve) 

Responsabilités:

En tant qu’Assistant(e) Administratif(ve), vous contribuez activement à l’amélioration continue du fonctionnement interne. Rapportant directement au Chief Operating Officer (COO), vous apportez votre support aux différents services en termes d’administration et d’organisation.

Vos principales tâches sont :

  • Traitement des demandes administratives et organisationnelles émanant des services internes.
  • Organisation des réunions : invitation, préparation du matériel, du catering et des supports de présentation.
  • Préparation et classement des factures entrantes et sortantes et autres tâches liées à la comptabilité.
  • Réalisation de diverses tâches administratives et logistiques liées aux ressources humaines.
  • Suivi des échéanciers administratifs et légaux.
  • Gestion de la boite mail générale et des communications téléphoniques.
  • Commande et suivi de matériel et de diverses fournitures.
  • Mise en page de fichiers et documents.
  • Organisation logistique de déplacements/voyages/salons/conférences.
Profil:
  • Vous disposez d’un Bachelor et d’une première expérience dans une fonction comparable.
  • Vous maitrisez parfaitement le français et possédez un très bon niveau en anglais (oral et écrit).
  • Vous vous épanouissez dans un rôle de support à l’équipe.
  • Vous êtes flexible et faites preuve de rigueur dans l’exécution des tâches qui vous sont confiées.
  • Vous planifiez et organisez adéquatement votre travail et les priorités.
  • Vous êtes dynamique et proactif(ve) et disposez de bonnes capacités de communication.
  • Vous maitrisez parfaitement les outils informatiques et la suite MS Office (Outlook, Excel, Word et PowerPoint).
  • Vous êtes en possession du permis de conduire B.
Offre:
  • Une fonction diversifiée au sein d’une start-up en forte croissance.
  • L’opportunité de rejoindre un environnement à taille humaine, dynamique et professionnel.
  • L’opportunité d’apporter un support efficace qui sera apprécié par toute l’équipe.
  • Possibilité de débuter par un contrat à durée déterminée en 3 ou 4/5ièmetemps, voire à temps plein.
  • Un package salarial attractif en phase avec votre expérience.
  • Localisation Illkirch/Strasbourg. Dynacure est situé dans le Parc d’innovation d’Illkirch, pôle pour la recherche et l’innovation au service du développement des entreprises de hautes technologies.
Intéressé(e)?

Food Complement Product Development Engineer - Biotechnology - Brabant wallon

A-MANSIA is a biotech company focusing on microbiome therapeutics addressing human health issues like obesity and related disorders. The mission of A-MANSIA is to provide innovative solutions based on Microbiome Therapeutics.

Under the implementation plan in the Walloon Brabant province and its future development, A-Mansia is searching for a dynamic and enthusiastic person to strengthen the team. For more information about the company and the technology, please contact us via recruitment@pahrtners.be.

A-Mansia offers a French, Dutch and English-speaking environment, culturally diversified and located in the heart of Europe, in Belgium, few hours from European Capitals.

To strengthen the team in Mont-Saint-Guibert (Belgium), we’re looking for (m/f):

Food Complement Product Development Engineer

Responsibilities:

Reporting directly to the R&D Nutrition Manager, you develop a new range of food complements based on intestinal microbes. You manage the full development cycle of a food complement.

Your main tasks are:

  • Take charge of the product development, from the conception to launch onto the market in close collaboration with other scientists, marketing and sales.
  • Coordinate the development, the implementation and the follow up of trials in a laboratory.
  • Manage the innovation and development strategy of new by-products.
  • Contribute to the creation, formulation, conception and feasibility assessment (technical, regulatory, packaging and costs).
  • Be the point of contact with CROs and CMOs regarding formulas validation, dosage, compatibility tests, galenic development and packaging.
  • Ensure the regulatory compliance with external resources, especially regarding the European regulations.
  • Take part in the creation mechanism of the new possible patent application.
Profile:
  • You hold a Ph.D., an Engineer or a Master’s degree in nutrition or Life Sciences, or equivalent by experience.
  • You have at least 5 years of industrial experience in launch of food complement/probiotics onto the market.
  • You master all the aspects of food complement development and related regulations.
  • You are proficient with “MS Project” or any other project management software.
  • You have a good understanding of patent creation mechanism. A successful experience in patent writing is an asset.
  • You like working independently within a team.
  • You are a rigorous, flexible, independent, dynamic and pro-active person.
  • You are fluent in English. The command of French and/or Dutch is an asset.
Offer :
  • A diversified position within a young and growing start-up.
  • The opportunity to join a human sized, dynamic and professional environment.
  • A permanent employment contract.
  • An attractive compensation package in line with your experience.