Regulatory Affairs Specialist
Regulatory Affairs Specialist (m / f / d)
As a Regulatory Affairs Specialist (m / f / d) you’ll take ownership of all Regulatory topics in a very critical role to the company’s future and help to fulfil relevant national and international regulatory requirements.
Your Responsibilities Will Include, But Are Not Limited To :
- Creation and update of 510(k) regulatory documentation for devices and instruments (Premarket Notification, Letter to File, etc.)
- Selection and justification Predicate Device (Performance)
- Verification of material suitability (Biokomp strategy)
- Ensuring the correct implementation of labeling
- Announcement / Listing and contact person for FDA
- Updating the documentation for product changes (LtF,
- Argumentation regarding change of intended use, etc.)
Key Requirements :
- Completed bachelor's degree
- Over three years of professional experience in Medical Device industry
- Fluent knowledge of English and German B2
- Sound knowledge of MS Office applications
- Very structured way of working
If you are interested in the role, apply online today.
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