PlusOne

Regulatory Affairs Officer - Medical Devices - Liège

Company

Our client is a high-potential biotech company specialized in the research and development, manufacturing and commercializing of innovative medical devices for regenerative medicine.

Our client has currently two products targeting orthopedic and tissues regeneration markets that will get CE-marked early 2020, and other innovative developments in the pipeline.

The team aims at succeeding the commercial launch and growth on its markets.

Role

  • You actively participate to the preparation and submission of the technical dossiers in Europe and outside Europe, as well as to the maintain of the existing technical dossiers.
  • You actively contribute to the action plan of the Quality Management System transition through to the European regulation concerning medical devices (MDR).
  • You collect, analyze and summarize the data from the post-market surveillance (PMS) in order to communicate them to the notified body.
  • You collect, analyze and process the feedbacks from the market concerning the marketed products requiring the recording of non-conformities or vigilance activities and some CAPA plans.
  • You contribute to the implementation of changes impacting CE-marked products, ensuring the consistency, maintenance and follow-up of the change management system and the corresponding action plans.
  • You actively participate to the regulatory and normative watch.

Profile

  • Master or PhD in science or in pharmacy.
  • Work experience in ISO 13485 and/or GMP system(s) and good knowledge of regulatory requirements concerning the medical devices (MDD and MDR).
  • Experience in RA, PMS and/or vigilance of 3-5 years.
  • Very good capacity of documents drafting.
  • Motivation to work in team in a dynamic environment.
  • Rigor, critical mind, analysis capacity and autonomy.
  • Strict respect of procedures, quality standards and regulations applicable to the company.
  • Good level of English (writing/speaking). French is an asset.

Offer

  • An opportunity to participate to the growth of a young and dynamic company in an innovative and fast-moving field, and particularly to the start of its commercial activity in the context of a new European regulation on medical devices.
  • A possibility of hiring with a permanent contract.

Publication date

23.01.2020

Contact person

Gaëlle Minet

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