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Principal Regulatory Affairs Specialist
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- Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care.
- With minimal oversight, the Pr. Regulatory Affairs Specialist (PRA) for the European Union Medical Device Regulation (MDR) will be responsible for supporting execution to MDR compliance plans to ensure all applicable technical files (for devices ranging from class I to class III) meet the EU MDR requirements on schedule.
- Independently develop comprehensive regulatory strategies relating to PMA, IDE, ITA, 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation, and Canadian license submission / amendments.
- Interact and negotiate with regulatory agencies / Notified Bodies to support product life cycle management, including FDA for Class II and III Pre-Submission Meetings and PMA submissions, Health Canada for Class III/IV submissions, and EU MDR Class I - IV submissions and change notifications.
- Provide regulatory review for reporting activities required by EU MDR (i.e. post-market surveillance, reporting, etc
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