About this opportunity
BRIOHEALTH SOLUTIONS INC lists this Senior Regulatory Affairs Specialist – MedTech (FDA/EU MDR) opportunity in burlington, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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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Worksite address
burlington, MA, 01805, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.