About this opportunity
BrioHealth Solutions, Inc. lists this Senior Regulatory Affairs Lead — Med-Tech Heart Devices opportunity in burlington, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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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Worksite address
burlington, MA, 01805, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.