Jobs

Define your goal, step up your career.

Cleaning & Packaging

No job found

Other career opportunities

40 results

Research Associate – Cellular Assays Immuno-oncology - Biotech - Gosselies

ImmunXperts is a high-potential start-up based in Gosselies, Belgium. This fast-growing company offers a wide range of Immunology services with a strong commitment to developing customized solutions for its clients.

The offerings include in vitro assays to assess the immunogenic potential of test molecules using T cell activation and proliferation assays as a surrogate marker for the induction of Anti-Drug-Antibodies. On the immuno-oncology side, ImmunXperts develops in vitro assays to assess the functionality of candidates. ImmunXperts continuously develops new cellular immune-assays to assist biotech and pharma companies directly in their product development. Other such collaborative services include protocol optimization and in-house training. More info can be found on www.immunxperts.com.

ImmunXperts’ team works in an open-minded, science-driven and fast-paced environment. In order to support their growth, ImmunXperts is actively looking to fill the following role (m/f):

Research Associate – Cellular Assays Immuno-oncology

As Research Associate, you will work closely with a growing team of Research Associates and lab technicians. Primarily, the immune-oncology cellular assay team to conduct, optimize and validate a wide variety of existing and new functional assays and help our clients characterize their therapeutic candidates. In function of the projects, you will also work with the other teams focusing on other immunological applications. Based on specific customer requests, you will need to employ your expertise in immunology, your analytical thinking and your problem-solving skills to design, test and confirm novel routes of predictive testing.

Key responsibilities
  • Perform cellular assays according to the Standard Operation Procedures
  • Participate in the development and optimization of cellular assays
  • Analyze data and write technical and scientific reports
  • Plan and organize your daily, weekly and monthly projects in coordination with the team to ensure delivery on budget and on time
  • Guide, train and support laboratory technicians to ensure quality work is delivered as planned
  • Support the sales and business development team in drafting and reviewing project proposals
  • Plan, coordinate and oversee progress of assigned projects intervening where necessary to stay on track
  • Manage suppliers, partners and subcontractors to ensure their roles are completed as expected
  • Report internally and externally (to client) on project progress and results
  • Respond to client inquiries and identify new project opportunities with returning clients
  • Reinforce and implement quality standards through continuous improvement strategies
  • Participate in conferences and review literature to stay up to date on progress in the field
  • Prepare and deliver technical and scientific presentations (talks, posters and webinars)
Experience
  • Master in Immunology, Biology, Pharmaceutical Science, or equivalent by experience
  • Experience working with primary cells
  • Hands-on expertise with cellular assays and immunological techniques, including flow cytometry. HTRF, Luminex and ELISpot are a plus
  • Strong grasp of assay development, validation and optimization methods
  • Previous work in direct contact with customers and service providers is a plus
Profile
  • 2 to 3 years’ experience in the pharmaceutical industry, biotech or CROs
  • Passionate and self-motivated Research Associate with ability to adapt to changing conditions
  • Excellent communication and organizational skills
  • Studious with attention to detail
  • Commitment to customer satisfaction
  • Comfortable working under pressure and with tight deadlines
  • Focus on quality and continuous improvement
  • Enjoys working in small teams and shaping the evolution of the company
  • Good English (written and spoken) skills

Responsable Maintenance et Facilities - Radio–Pharma - Fleurus

Situées à Fleurus (Belgique), l’IRE et sa filiale IRE ELiT sont des entreprises industrielles renommées et innovantes jouissant d’un potentiel de développement élevé.

Avec près de 250 collaborateurs, l’IRE est l’un des principaux producteurs mondiaux de radio-isotopes utilisés en médecine nucléaire à des fins de diagnostic et de thérapie. IRE ELiT est quant à elle active dans la production radio-pharmaceutique.

Plus concrètement, ces entreprises contribuent à sauver des millions de vies dans le monde chaque année. Sur les 5 dernières années, l’entreprise a renforcé son développement et jouit d’une croissance continue. Pour plus d’informations, veuillez consulter www.ire.eu

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

Responsable Maintenance et Facilities

Responsabilités :

Rapportant au Directeur des Opérations, vous gérez et optimalisez les activités de maintenance de l’outil de production et de l’Infrastructure. Vous dirigez une équipe d’environ 30 personnes.

Les responsabilités suivantes vous sont confiées :

  • Définir et mettre en place la stratégie de la maintenance à moyen et long terme.
  • Élaborer, suivre et optimiser le budget de la maintenance des équipements.
  • Diriger, motiver et développer les collaborateurs du département.
  • Élaborer et implémenter la TPM au niveau de la maintenance.
  • Veiller aux indicateurs de performances et atteindre les niveaux de services attendus.
  • Déployer le programme de gestion de la maintenance (GMAO).
  • Promouvoir la dynamique d’amélioration continue au sein du département.
  • Être le point de contact technique avec les institutions externes.
  • Développer un partenariat avec la délégation syndicale.
Profil :
  • Vous êtes Ingénieur ou équivalent par expérience.
  • Vous disposez d’environ 10 années d’expérience dans une fonction comparable au sein d’un environnement industriel, de préférence en milieu pharmaceutique/biotech.
  • Vous appréciez les environnements industriels sous hautes contraintes de qualité.
  • Vous êtes orienté(e) solutions et faites preuve d’assertivité et de diplomatie.
  • Vous faite preuve de leadership et d’une forte capacité organisationnelle et relationnelle.
  • Vous jouissez d’une très bonne connaissance du français et de l’anglais.
  • Vous êtes orienté(e) résultats et solutions, rigoureux/se, pragmatique et autonome.
Offre :
  • Une fonction diversifiée incluant des responsabilités et des projets intéressants.
  • Des défis professionnels, techniques et humains enrichissants.
  • Intégrer une structure industrielle renommée et innovante en pleine croissance.
  • Un salaire attractif reprenant des avantages extra-légaux, en ligne avec votre expérience.

Research Scientist Translational medicine – Immuno-oncology - Bio-Pharma/Biotech - Gosselies

iTeos Therapeutics is a publicly-held (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing next generation immunotherapies. Based in Gosselies, Belgium and Cambridge, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UCLouvain) in 2011.  In March 2020, iTeos Therapeutics completed a $125 million Series B2 financing, and in July 2020, the company completed its IPO raising over $200million of proceeds.  This additional capital will allow the company to continue to develop its clinical pipeline and expand its preclinical pipeline by investing in the discovery research team.

iTeos Therapeutics’ innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology pathways. EOS-850, is designed as a highly selective small molecule antagonist of the adenosine A2a receptor, a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors. EOS-850 is being investigated in an open-label Phase 1/2a clinical trial in adult patients with advanced solid tumors. The lead antibody product candidate, EOS-448, is an antagonist of TIGIT, also designed to engage the Fc gamma receptor, or FcγR,. An open-label Phase 1/2a clinical trial of EOS-448 is currently ongoing in adult patients with advanced solid tumors. iTeos Therapeutics also continues to expand its pipeline through internal research efforts and external collaboration with leading scientists.

For more information, please visit www.iteostherapeutics.com.

To reinforce its translational medicine team, iTeos Therapeutics is currently looking for a (m/f) :

Research Scientist

Translational medicine – Immuno-oncology

 

Responsibilities :

Within the Translational Medicine team, you will play a key role in the evaluation of the mechanisms of action of our immune oncology drugs in clinical development and support the selection of biomarkers. You will generate robust in vitro data on the products under clinical development, helping to interpret data obtained in clinical trials and refining our biomarker strategy.

Your main responsibilities will be to :

  • Coordinate with colleagues from the Translational Medicine or Pharmacology teams, design and perform independently complex experiments to assess the function and effect of iTeos drugs and to test new biomarkers in various immunology systems (i.e. immunophenotyping experiments, functional immunoassays as well as molecular biology and ELISA-based assays in human samples).
  • Identify and establish in the laboratory relevant immunoassays and technical approaches.
  • Compile, document, critically analyze experimental results in order to present them at project team meetings.
  • Show strong ownership by being up to date with the project literature and more broadly with the immune-oncology field.
  • Write technical reports and contribute to scientific articles.
  • Share your expertise e.g. in immunoassays with other people and other teams within the company.
  • Collaborate with external contacts, either with academic partners or with CRO’s.

 

Profile :
  • PhD and/or post-doc in (Tumour) Immunology.
  • Hands-on experience in the biotech/pharma industry would be valued and give you access to the Senior Scientist position.
  • Strong expertise in immunology techniques including functional immunoassays (e.g. in vitro stimulation of immune cells) and multi-parametric flow cytometry.
  • Strong background in molecular biology assays (such as qRT-PCR, NGS is a plus).
  • Previous experience in handling human blood samples and/or tissues for primary cell isolation is required.
  • Excellent command of English (oral and written), French is a plus.
  • Committed and detail-oriented, strong sense of time management and flexibility.
  • You are both autonomous and a team player with an inquisitive mindset and strong problem-solving skills.
  • You are very open-minded and have excellent interpersonal and communication skills.

 

Offer :
  • A stimulating position within a high-potential innovative biotech company.
  • The opportunity to work in a science-driven, dynamic, human‐sized, respectful and professional environment.
  • A challenging scientific and business growth in which you get to bring your knowledge and skills.
  • An extensive networking inside the company, the biotech/pharma sector and the scientific world.
  • A permanent contract with an attractive salary package in line with the position responsibilities and your experience.

C/C++ Software Engineer - Engineering, Innovation, Transport - Genval

Founded in 2013, E2 Drives is an innovative start-up company active in electric mobility. The company is specialized in mechanics, electronics, electric motor and embedded control software. Recently, E2 Drives has developed a high-end and disruptive new generation of electric bikes. The key differentiator of the bike is its all-in-one drive unit integrating an electric assistance and an automatic gearbox.

E2 Drives’ ambition is to develop and commercialize the best electric bike on the market, in the commuting segment, with premium functions and an affordable price. The team is currently composed by 5 dynamic and entrepreneurial persons but will strongly grow this year.

E2 Drives, future top player of the electric bikes market, is based in Genval (South-East of Brussels).

In order to strengthen the team in Genval, we are looking for a (m/f):

C/C++ Software Engineer

Responsibilities:

Reporting to the CTO, you develop RTOS C++ embedded firmwares for the central IoT board of the innovative bikes. Based on market and testrides feedbacks, you identify and implement new solutions and technical upgrades.

Your main responsibilities are:
  • You propose and implement the roadmap of RTOS C++ embedded firmware of the central IoT board with focus on quality, robustness and timing.
  • You identify, propose, implement new and existing connected functions (including BLE, 3G, NB-IoT, GPS, NFC stacks).
  • You work in a broader way on the overall behaviour of the connected bike.
  • You test/debug and validation of technical upgrades.
  • You are in charge of your own projects and collaborate within the software development team.
  • You report work evolution on a regular basis.
Profile:
  • Master degree in engineering, IT, computer science, or equivalent through experience.
  • 3 to 5 years’ experience in a software engineer position within the industry.
  • Experience in C/C++ firmware development with RTOS, and several communication peripherals (BLE, 3G, NB-IoT, GPS, NFC…) and sensors from the IoT world. Familiar with Git.
  • Analytical, problem solving skills, rigorous, autonomous and results oriented.
  • Familiar with failure analysis and code robustification.
  • Command of bootloader, authentification, and encrypted firmware updates are a plus.
  • Knowledge in STM32 family peripherals is a plus.
  • Fluent in French or in English.
Offer:
  • A challenging position within a high-potential innovative start-up.
  • To join an electric bikes company with a worldwide ambition.
  • The opportunity to work in a human-sized, dynamic and excellence-oriented environment.
  • An attractive salary package in line with the position responsibilities and its context.
  • A full-time permanent contract.

Site Manager - Industry - Région de Charleroi

Notre client est une entreprise industrielle spécialisée en fabrication de pièces métalliques à destination des professionnels de la construction.

Située dans la région de Charleroi, la société est composée d’une vingtaine de collaborateurs passionnés et motivés. Notre client dispose de son propre parc de machines et met en œuvre un nouveau plan d’investissement pour renforcer son positionnement sur le marché pour les années à venir.

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

Site Manager

Responsabilités :

En tant que Site Manager, vous dirigez le site industriel alliant les activités de fabrication, de planification, d’achat, de maintenance et de vente. Vous faites vivre la vision et les valeurs du groupe, tout en respectant les spécificités et la valeur-ajoutée locale. En outre, vous assurez la qualité, la sécurité et l’amélioration continue des activités. Vous contribuez activement au développement commercial des activités.

Vos principales responsabilités sont les suivantes:

  • Gestion du développement commercial, et de la santé financière du site.
  • Coordonner et optimiser le fonctionnement des opérations, ainsi que des achats..
  • Diriger, motiver et développer les collaborateurs de l’équipe.
  • Mettre en œuvre la stratégie de l’entreprise au sein du site, et veiller à l’amélioration continue.
  • Garantir l’application des règles de sécurité, des normes de qualité et du règlement intérieur.
  • Rapporter de manière structurée, rigoureuse et adaptée les résultats des activités.
Profil :
  • Vous êtes titulaire d’un diplôme de Master, d’Ingénieur ou équivalent par expérience.
  • Vous disposez de 10 ans d’expérience dans une fonction comparable en environnement industriel
  • Vous communiquez efficacement, avec assertivité, et possédez une certaine aisance relationnelle.
  • Vous êtes à l’écoute et faite preuve d’empathie envers vos collaborateurs.
  • Vous faites preuve de leadership, et démontrez des compétences en change management.
  • Vous parlez couramment Français et avez une bonne maitrise de l’Anglais. La connaissance du Néerlandais est un atout.
  • Vous vous déplacez ponctuellement chez les fournisseurs et/ou clients.
Offre :
  • Une fonction diversifiée au sein d’une industrie reconnue pour la qualité de ses produits.
  • Des défis opérationnels, commerciaux et humains stimulants et enrichissants.
  • L’opportunité de développement et d’évolution en termes de responsabilités.
  • Un salaire attractif reprenant des avantages extra-légaux en phase avec votre expérience.

Senior R&D Director - Medical Device - Belgium

Our client is a high-potential MedTech start-up company based in Belgium. They develop high-end innovative and disruptive therapies aiming to improve and save patients’ lives. The Company is financially backed by strong international investors and shows great business ambition.

In order to lead strategic R&D projects critical to the Company, we are looking for a (m/f):

Senior R&D Director


Responsibilities:

As a Senior R&D Director, you lead strategic R&D projects, especially in soft- and hardware components. Reporting to the CEO, and as a member of the Management Executive Committee, you lead innovation within the Company.

Your main responsibilities are:

  • You lead strategic R&D projects from a to z: specifications, design, prototype, industrialisation, manufacturing, and commercial release.
  • You ensure resources, processes, procedures and controls are adapted to the projects’ needs.
  • You lead internal and external project teams with respect to timelines, budgets, quality, safety and business requirements.
  • You analyze the market, select, lead and manage suppliers, vendors, contractors and external partners in order to meet the innovation goals.
  • You take account of medical safety requirements, FMEA and risk analysis. You prepare validation plans in line with company documentation, CE and FDA requirements and industry standards.
  • You lead development and manufacturing activities in compliance to the Quality Management Systems (ISO 13485 environment).
  • You are a key person of contact for KOL, scientific experts and governmental authorities.
  • You report results and work evolution on a regular basis to the top management.
  • You assist the CEO in representing the Company to internal and external stakeholders.
Profile:
  • Engineering Master’s degree or PhD in Electronics, IT or related fields.
  • 10 years’ experience in R&D positions within MedTech companies.
  • Expertise in hard- and software technologies.
  • Excellent project management methodologies and tools.
  • Strong leadership and communication skills 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.
  • Excellent oral and written communication skills in English. Any other language is a plus.
  • You are likely to travel up to 20% of your work time.
  • Despite joining at senior level, you are a hands-on person and can lead and manage the team as well as perform some of the work at task.
Offer:
  • A leading and challenging position within a high-potential innovative MedTech.
  • To work in a human size, dynamic, respectful and professional environment.
  • International exposure, with development and evolution opportunities.
  • Varied contacts through external collaborations and partnerships.
  • An attractive salary package in line with the responsibilities and your experience.

Electric Motor control Engineer - Engineering, Innovation, Transport - Genval

Founded in 2013, E2 Drives is an innovative start-up company active in electric mobility. The company is specialized in mechanics, electronics, electric motor and embedded control software. Recently, E2 Drives has developed a high-end and disruptive new generation of electric bikes. The key differentiator of the bike is its all-in-one drive unit integrating an electric assistance and an automatic gearbox.

E2 Drives’ ambition is to develop and commercialize the best electric bike on the market, in the commuting segment, with premium functions and an affordable price. The team is currently composed by 5 dynamic and entrepreneurial persons but will strongly grow this year.

E2 Drives, future top player of the electric bikes market, is based in Genval (South-East of Brussels).

In order to strengthen the team in Genval, we are looking for a (m/f):

Electric Motor control Engineer

Responsibilities:

Reporting to the CTO, you develop embedded firmware for the motor control PCB. Based on internal objectives, you, on one hand, focus on tasks as improving motor control performance and on the other hand identify and implement more broader algorithm to control the whole drive unit of the electric bikes.

Your main responsibilities are:
  • You will propose and draw up the roadmap and its implementation in C of the electric motor control and more broadly the drive unit control.
  • You improve step response, improving efficiency, lowering ripples, increasing torque per ampere of our current PMSM FOC (also called dq, vector) control.
  • You adapt our control to IPM motor.
  • You lead C firmware developments, maintain, upgrade with regards to quality, robustness (by failure analysis) and timing.
  • You are in charge of your own projects and collaborate within the software development team.
  • You report work evolution on a regular basis.
Profile:
  • Master degree in engineering or equivalent through experience.
  • 3 to 5 years’ experience in a software engineer position within the industry.
  • Experience in time-critical C firmware development, PMSM and IPM control (FOC) and its low level constaints (Timing, Sampling, Filter delays, PWM updates opportunity…). Git or SVN familiar.
  • Analytical, problem solving skills, rigorous, autonomous and results oriented.
  • Familiar with failure analysis and code robustification.
  • Command of bootloader, authentification, and encrypted firmware updates are major assets.
  • Knowledge in STM32 and/or Kinetis families’ peripherals is a plus.
  • Fluent in French or in English.
Offer:
  • A diversified and challenging technical position within a experienced team in a fast growing start-up.
  • The opportunity to enter a sustainable development and green tech company.
  • Varied contacts with professionals on an international scale.
  • Significant learning and evolution opportunities.
  • An attractive salary package coherent with your experience.
  • A full-time permanent contract.

Assistant(e) Comptable et Administratif(ve) - Engineering, Innovation, Transport - Liège

Notre client est une start-up belge innovante basée à Liège. Son équipe, composée d’une vingtaine de personnes, est professionnelle, agréable et dynamique. La start-up est soutenue par d’importants investisseurs internationaux et possède un fort potentiel sur le marché.

Afin de poursuivre sa croissance, notre client recrute un(e):

Assistant(e) Comptable et Administratif(ve)

Responsabilités :

En tant qu’Assistant(e) Comptable et Administratif(ve), vous supportez les démarches comptables et administratives de la société. Rapportant au Finance Manager, vos principales responsabilités sont les suivantes :

  • Gestion des procédures comptables applicables au sein de la société: encodage de factures, notes de crédit, dépenses, etc.
  • Gestion des extraits bancaires et des affectations électroniques.
  • Gestion et suivi des fournisseurs d’un point de vue comptable.
  • Gestion de la documentation et des procédures administratives et juridiques de base (réponses à demandes d’informations, relecture et analyse de contrats, suivi auprès du secrétariat social…).
  • Supervision et coordination des procédures administratives : suivi et validation des chèques-repas, gestion des temps de travail (relations avec le secrétariat social).
  • Aide à l’organisation et planification de réunions, évènements, rendez-vous ou déplacements.
  • Assistance au management dans des tâches administratives, RH, ou comptables.
Profil :
  • Vous disposez d’un Bachelier en Comptabilité, Assistant de direction, Gestion d’entreprise ou bénéficiez d’expérience similaire probante.
  • Vous avez une réelle motivation pour l’encodage des documents comptables. Disposer d’une expérience avec un ERP et avec les tâches administratives est un plus.
  • Vous maîtrisez le français, et possédez un bon niveau d’anglais (écrit et oral).
  • Vous avez d’excellentes capacités relationnelles, rédactionnelles et communicationnelles.
  • Vous êtes rigoureux/se, organisé(e) et vous planifiez adéquatement votre travail et vos priorités.
  • Vous faites montre d’une bonne résistance au stress, d’une forte autonomie et de flexibilité. Vous être responsable, dynamique, proactif(ve) et pragmatique.
  • Vous êtes volontaire et êtes capable de travailler en équipe.
  • Vous maitrisez la suite MS Office (word, excel, outlook).

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’entrer dans une position évolutive d’un point de vue du contenu du travail.
  • Un contrat à durée indéterminée, avec possibilité de débuter par un 4/5ième
  • La possibilité de réaliser une entrée en fonction rapide.
  • Un package salarial attractif en phase avec votre expérience.

 

R&D Engineer – Catheter - Medical Device - Belgium

Our client is a young MedTech start-up company located in Belgium. They develop innovative products in the coronary business. The Company is financially backed by strong international investors and shows great business ambition.

In order to lead strategic R&D projects critical to the Company, we are looking for a (m/f):

R&D Engineer – Catheter


Responsibilities:

As a R&D Engineer – Catheter, you will lead and take care of designing, developing and testing next-generation catheter delivery systems from concept to human use. Reporting to the Senior Director R&D you play a key role in the R&D/innovation activities.

 

Your main responsibilities are:

  • Conceptualize, design and develop innovative interventional catheters, including design requirements, prototype developments, pre-clinical and clinical assessments, and industrialization.
  • Support the design of the next generation catheter components, in collaboration with Quality.
  • Support the development of new test methods, tooling and equipment procurement, and executing long term testing for catheters.
  • Collaborate with colleagues and physicians in both pre-clinical and clinical developments in order to evaluate technology and to have a better understanding of cardiovascular anatomy.
  • Work with team members and external partners to deliver project’s technical objectives.
  • Report results and work evolution on a regular basis to the top management.
  • Establish timelines and ensures adherence to timely execution.
  • Develop appropriate test methods for product evaluations, write and execute test protocols and test reports required per GMP and regulatory submissions.

 

Profile:
  • Mechanical or Biomedical Engineering Master’s degree.
  • 3 to 10 years’ experience in design, development and industrialization within medical device companies.
  • Experience in materials (plastics, adhesives and associated processes), and mechanical (small part) design.Experience with catheters is a strong asset.
  • Experience in medical device regulatory requirements, QMS and design control processes is an asset.
  • Relevant technical expertise on extrusion, braiding, molding, and bonding processes.
  • Proven record of working with and managing vendors for product and process specification and testing.
  • Strong innovation and 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.
  • Excellent oral and written communication skills in English. Any other language is a plus.
  • Up to 25% travel may be required.

 

Offer:
  • A challenging position with a high potential innovative medical device company.
  • To work in a human-sized, collaborative and respectful environment.
  • A variety of interesting contacts with international exposure.
  • An attractive compensation package in line with your responsibilities and experience.

Quality Assurance and Regulatory Affairs Manager - Biotech, Biotechnology - Flémalle

Created in 2013, Wishbone is an innovative start-up located in Flemalle (Liege). Wishbone is engaged in the development of intraoral bone regeneration biomaterials. The company has launched its industrialization and production activities in a brand new production unit and has successfully reached ISO 13485 certification.

The goal of Wishbone is to develop superior bone graft substitute products with breakthrough technologies and innovative procedures, and thus improve patient well-being and contribute to a better environment. The company will launch its forst commercial product and several other innovative products are under development. For more information please visit: www.wishbone-biotech.com

To support this challenging development, we are looking for a (m/f):

Quality Assurance and Regulatory Affairs Manager

Responsibilities:

As a Quality Assurance and Regulatory Affairs Manager, you are responsible for managing the company Quality Management System and its related activities. You are also responsible for the Regulatory Affairs Management. You ensure the company and the products are compliant with the appropriate standards and regulations. You provide support in the Quality Management System maintenance and improvements. This includes the development of systems, policies/procedures and programs to ensure compliance with the EU and FDA regulations, ISO standards, and other international requirements.

You have a cross-functional role, directly manages a small team of QA/RA Associate and Product Specialist and interact with all departments and with the top management.

Your main responsibilities are :
  • Managing the Quality Management System according to the EU ISO 13485, the US FDA 21 CFR Part 820 and any other relevant regulatory requirements in accordance with the Quality Policy.
  • Ensuring that required processes of the Quality Management System (QMS) are documented, established, implemented and maintained.
  • Assuring that products have been supplied, manufactured, analyzed and released according to specifications and approved SOP’s and to appropriate standards and regulations.
  • Organizing and documenting the Management Review according to the company QMS. Recommending and driving improvement.
  • Performing supplier audits, internal and external audits and interacting with suppliers and customers to deal with non-conformities and drive continuous improvement.
  • Supporting activities for CE marking and FDA approval certification of products as well as maintaining the documentation up to date when changes to the product occur, dealing with notifications and amendments when required.
  • Managing materiovigilance activities including incident and post-market surveillance reporting.
  • Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
  • Reporting to the management on the effectiveness of the Quality Management System and any need for improvement of the company organization.
Profile:
  • Scientific Master’s degree, or equivalent through experience.
  • At least 5 years of experience in QA management positions in the medical devices industry.
  • Strong understanding of regulations and guidelines governing medical devices (e.g. CFRs, ISO 13485, MDD, MDR).
  • Strong leadership, project management and communication skills together with hands-on and pragmatic mind-set.
  • Ability to work in a start-up environment where accuracy, accountability, quality, safety and timeliness are essential.
  • Highly collaborative, self-motivated and team-oriented individual in a company setting.
  • Excellent oral and written communication skills in French and English. 
Offer:
  • The opportunity to join an innovative medical device company, a fast-growing start-up environment where teamwork, results and patient care are very important.
  • A challenging and diversified position in a dynamic, young and nice
  • To work in a human size, respectful and professional environment.
  • An attractive compensation package in line with the position responsibilities and your experience.