Regulatory Affairs Specialist
il y a 7 jours
A key role in ensuring the compliance of medical devices with regulatory frameworks.
Key Responsibilities:- Implement Quality Management Systems at client sites, based on our developed framework.
- Develop regulatory strategies for the introduction of innovative medical devices on the market.
- Support clients in achieving compliance with regulatory requirements.
- Good understanding of Medical Devices and IVD regulatory environment (directives, regulations).
- Knowledge of Medical Devices quality assurance (ISO 13485, 21 CFR) and relevant standards.
- Proficiency in French, Dutch, and English for communication with clients and team members.
- A comfortable and spacious office with green surroundings.
- Meal vouchers (8 euros/day) and supplemental health insurance.
- Complementary pension and public transport costs covered.
- Training opportunities and well-being workshops.
We are looking for a skilled professional to join our team and contribute to the success of our clients in the medical device industry.
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