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Medical Device Regulatory Strategist
2 weeks ago
The Senior Specialist in Regulatory Affairs is responsible for post-market activities for medical devices, supporting departmental regulatory processes and procedures.
Main Responsibilities:- Develop and execute regulatory strategies for OUS medical devices and combination products.
- Create regulatory documentation such as CIAs, Technical Documents, PMS Plans, PSURs, PMCF and vigilance reports.
- Perform global Post Market Surveillance (PMS) activities and assignments for OUS medical devices and combination products.
- Proven experience with EU MDD (93/42/EEC), EU MDR (2017/745), ISO 13485, US FDA regulations, and EU combination product regulations.
- Strong analytical, decision-making, communication, and technical writing skills.
- Ability to work independently and manage multiple priorities effectively.
- This position includes supporting internal and external customer regulatory requests, collaborating closely with cross-functional teams.
- The ideal candidate will have direct engagement with regulatory authorities and familiarity with US drug-device and ROW combination product requirements.
This opportunity offers a unique chance to leverage your expertise and drive successful regulatory outcomes in a dynamic environment.
