A client of ours is looking to bring on a Regulatory and Quality Manager position to report directly to their VP of QA/RA at an industry leading medical device company in the Greater Boston Area.
This position is fully on-site, offering competitive base salary.
Position Requirements
Medical device experience is a MUST
Background in Quality Assurance AND Regulatory Affairs within the medical device space.
QMS knowledge
510(K) submissions
Clinical Submissions and Clinical Trials experience
Experience with EU MDR and EU medical device requirements
Experience with ISO 13485 and related standards
Experience with MDSAP
Internal auditing experience is a plus
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
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