Regulatory Affairs Specialist
vor 3 Wochen
Job Overview
Envista is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to maintain market access.
Key Responsibilities
- Coordinate projects to implement new regulatory requirements and support other departments in complying with these regulations.
- Support development projects for RA aspects, creating development-related and technical documentation for medical devices, and 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.
Requirements
- Master's degree in Biomedical Science, Chemistry, Pharmacy, Natural Science, or equivalent.
- Minimum 3 years of experience as a 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, and international approval requirements.
- Experience in registration of medical devices in Japan is an advantage.
- Creation and updating of plans and reports according to MDR (e.g., SSCP reports, PSUR).
- Fluent in English, both in conversation and in writing. German is an advantage.
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