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Ans (Liège), Belgium

Regulatory Affairs Manager (M/F)

  • Experience 5 to 7 years 7 to 10 years 10 years or more
  • Type of role Regulatory & Medical Affairs
  • Region Wallonia
  • Activity Medical devices

Contact Isabelle Milcent
Email
+32 (0)472 11 13 37

More info on Trasis

Based in Ans (Liège), Trasis is a fast-growing innovative MedTech, active in Nuclear Medicine and Radiopharmacy. Its goal is to enable medical and scientific communities to access new treatments and diagnostic tools for (e.g.) cancer, Alzheimer’s and Parkinson’s diseases.

With 120 employees, Trasis develops and manufactures medical devices in the whole world. They’re used within hospitals, research centers, radiopharmaceutical production facilities and pharmaceutical companies.

Over the next 5 years, Trasis aims to confort its place within global leaders on the market. The company will double its workforce, reinforce its global presence and diversify its product portfolio. To that end, the company relies on a significant innovation force.

Trasis offers a young and friendly working atmosphere as well as a flexible and dynamic environment. For more information, please visit www.trasis.com

In order to support Trasis’ growth, we’re actively looking for a (m/f) : Regulatory Affairs Manager.


Responsibilities :

Reporting directly to the Head of Quality Assurance & Regulatory Affairs, you provide regulatory advice to project teams in strategic planning and associated submissions to support the development of Trasis’ products. You help define the data and information required for regulatory actions in collaboration with all teams associated to the project. You ensure compliance with applicable regulations through the development of best practices, procedures and existing systems in regulatory affairs. You ensure that the timelines for the submission of registration dossiers are respected.

Your main responsibilities are :

  • You plan and coordinate the constitution and follow-up of registration files (IMPD/AMM/DMF/CE mark) according to the established schedule and in compliance with the regulations and guidelines.
  • You organize, plan and write procedures related to regulatory affairs.
  • You are the point of contact for other departments on regulatory aspects (Development, Production, Quality, Marketing, Sales, …).
  • You manage databases and archiving of registration files.
  • You define and implement Trasis’ regulatory strategy.
  • You define the registration strategy for recording variations and updating of product files.
  • You ensure the monitoring of national and international regulations as well as the dissemination of this information within the company if necessary.
  • You develop and maintain a network of external experts.
  • You apply the procedures of the Quality Management System.

Profile :

  • You hold a Scientific Master’s degree (Engineering, Pharmacy, Chemistry) or equivalent through experience.
  • You have at least 5 years of Regulatory experience (medical devices and/or drugs). An experience within a radiopharmaceutical environment is an asset.
  • You have a strong knowledge of European regulation, especially for obtaining registration numbers.
  • You are rigorous and have strong interpersonal and organizational skills.
  • You are fluent in French or any other language is an asset.

Offer :

  • A challenging and diversified position within an innovative company.
  • The opportunity to work in a human-sized, collaborative and respectful environment.
  • A full-time permanent contract with an attractive salary package, in line with the position responsibilities and your experience.

Your application and related information will remain strictly confidential.

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