Unknown Company

Senior Regulatory Affairs Specialist – MedTech (FDA/EU MDR)

burlington, ma • Posted 3 weeks ago
Onsite Full Time Bio & Pharmacology & Health

BRIOHEALTH SOLUTIONS INC, based in Massachusetts, seeks a Senior Regulatory Affairs Specialist to lead FDA submissions and regulatory planning for BrioVAD LVAS. You will partner with cross-functional teams to ensure compliance across US and EU programs, including IDE/PMAs and CE marking activities.

The role requires strong technical writing and the ability to manage tight timelines in a fast-paced environment, supporting regulatory strategies and body interactions.

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Senior Regulatory Affairs Specialist – MedTech (FDA/EU MDR) in burlington at Unknown Company

This position is listed as full time and onsite.

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