Unknown Company

Senior Regulatory Affairs Lead — Med-Tech Heart Devices

burlington, ma • Posted 2 weeks ago
Onsite Full Time Legal

BrioHealth Solutions is seeking a Senior Regulatory Affairs Specialist to support the BrioVAD LVAS. This role partners with clinical, R&D, quality, and medical affairs teams to drive regulatory planning, submissions, and lifecycle management.

You will manage FDA submissions, advise on labeling and study documentation, and help navigate EU MDR and CE marking efforts for class III devices. Candidates should bring strong technical writing and project leadership.

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Senior Regulatory Affairs Lead — Med-Tech Heart Devices in burlington at Unknown Company

This position is listed as full time and onsite.

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