Regulatory Affairs Officer
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
- 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
Marieke Franken: firstname.lastname@example.org or 016 309 509