Become the expert on regulatory for the medical devices the company is distributing in the Benelux.
General RA work- 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.
Creation and/or control of artworks for medical devices - Checking of proof of artworks for the medical devices using Catalyst/Fusion
Answering 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 of 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
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