Sr Regulatory Affairs Specialist (Medical Device)

Sr Regulatory Affairs Specialist (Medical Device) (1086663)

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Sr Regulatory Affairs Specialist (Medical Device) (1086663)

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Join to apply for the Sr Regulatory Affairs Specialist (Medical Device) (1086663) role at The Judge Group

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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
  

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:
This job and many more are available through The Judge Group. Find us on the web at

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Business Consulting and Services

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