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Regulatory Affairs Officer

16/04/2019
- Vilvoorde

Job content

As the Regulatory Affairs Officer, you will,

  • Become the expert on regulatory for the medical devices the company is distributing in the Benelux. 
  • Execute general RA work- (eg submission of regulatory documents on request of the local regulatory authorities in the Benelux, classification of the proof of artworks, correspondence of authorities and with global concerning the product labelling).
  • Work with tender team on all regulatory aspects concerning the medical devices from the company.
  • Provide regulatory input to obtain tender agreements.
  • Look for better ways to inform customers about our medical devices. 
  • Create and/or control artworks for medical devices: checking of proof of artworks for the medical devices using Catalyst/Fusion
  • Answer questions from other departments in the company concerning ingredients and other regulatory aspects and help the medical team in answering specific medical devices questions. 
  • Review promotional material to ensure compliance with license particulars for the medical devices the company is distributing in the Benelux 
  • Keep abreast of European and local legislation, guidelines and regulations and ensure timely implementation.
  • Notify responsible persons in the company organisation if local requirements differ from those in force in the EU
  • Participate in Industry Association meeting in the Benelux
  • Participate in and prepare for internal and external audits and inspections as required as regulatory experts for the medical devices
  • Update of procedures in context of RA processes

Profile
  • Master Degree in Biomedical Sciences
  • A first experience in RA is a plus but no must
  • Fluent in Dutch/French/English
  • Accurate, organized and flexible
  • Well-developed administration, communication and computer skills
  • Willingness to learn, enquiring mind, result driven, quality focus
  • Strong team player with the ability to work independently
Contact

Marieke Franken: marieke@arcq.be or 016 309 509