JobsUSASr Regulatory Affairs Specialist (Medical Device)
Company : The Judge Group
Location : Framingham, MA, 01704
Posted Date : 15 September 2025
Job Details
Sr Regulatory Affairs Specialist (Medical Device) )
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Sr Regulatory Affairs Specialist (Medical Device) )
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Location: Framingham, MA
Salary: $135,000.00 USD Annually - $155,000.00 USD Annually
Description
Our client is currently seeking a Senior Regulatory Affairs Specialist. This is a permanent, direct hire, fully on-site position.
Key Responsibilities
Medical Device experience required.
- Prepare and submit global regulatory applications (Japan, India, China, etc.)
- Support U.S. medical submissions (Pre-Submissions, 510ks, IDEs, EU MDR)
- Review device labeling and advertising materials for compliance
- Assess design and manufacturing changes for regulatory impact
- Maintain regulatory files and tracking databases
- Support audits by notified bodies and government agencies
- Obtain Medical Device Certificates to Foreign Government (CFGs)
- Oversee post-market surveillance and complaint review
- 5-10 years of global regulatory affairs experience
- Strong knowledge of FDA QSRs, ISO 13485, ISO 14971, IEC 60601, 60825
This job and many more are available through The Judge Group. Find us on the web at
Seniority level
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Mid-Senior level
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