Sr Regulatory Affairs Specialist (Medical Device) at The Judge Group Inc. in Framingham, Massachusetts

Job Description:

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.

Medical Device experience required.

Key Responsibilities:

• 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

Requirements:

• 5-10 years of global regulatory affairs experience
• Strong knowledge of FDA QSRs, ISO 13485, ISO 14971, IEC 60601, 60825

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Contact: jgood@judge.com


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