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Senior Regulatory Affairs Specialist
vor 4 Monaten
Operating Company: Nobel Biocare
Location: Herzogenrath,Nordrhein-Westfalen,DE
Date Posted: March 24, 2024
Req Number: R5019229
**Primary duties & responsibilities**:
- Coordination of projects to implement new regulatory requirements (i.e. MDR (EU) 2017/745) and supporting other departments to comply with these regulatory requirements
- Supporting development projects for RA aspects, creating development-related and technical documentation for medical devices, editing existing technical documentation
- Communicate and work with national and international Regulatory Affairs agencies
- Support the development of national and international regulatory strategies
- Initiate and implement projects for new or updated regulatory requirements to ensure continuous market access
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**Job Requirements**:
- Master or comparable academic degree in Biomedical Science, Chemistry, Pharmacy, Natural Science or equivalent
- Minimum 3 years´ experience as Regulatory Affairs Specialist in the field of medical technology, preferably in an international context
- In-depth knowledge of standards and regulations such as: ISO 13485, ISO 14971, 21 CFR part 820, MDSAP, MDR, international approval requirements
- Experience in registration of medical devices in Japan would be an advantage
- Creation and updating of plans & reports according to MDR (e.g. SSCP reports, PSUR)
- Languages: Fluent in English, both in conversation as well as in writing. German is an advantage.
**Operating Company**:
Nobel Biocare
