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Regulatory Affairs Specialist
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Full-time
- Role: Regulatory Affairs Specialist III
- Serves as the Regulatory Affairs lead on cross-functional MDR project teams
- Ensures compliance with EU Medical Device Regulations (MDR) and EU guidance throughout the project.
- Actively participates in EU MDR project teams by attending meetings, collaborating with the project manager and cross-functional team members, and communicating regulatory requirements and guidance for the technical documentation.
- Prepares and submits EU MDR technical documentation submission for applicable device per project schedule.
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