Get new jobs for this search by email

Sr Regulatory Affairs Specialist (Medical Device) (1086663)

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

Sr Regulatory Affairs Specialist (Medical Device) (1086663)

1 week ago Be among the first 25 applicants

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

Get AI-powered advice on this job and more exclusive features.

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
  

By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
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

Referrals increase your chances of interviewing at The Judge Group by 2x

Get notified about new Senior Regulatory Affairs Specialist jobs in Framingham, MA .

Sr Regulatory Affairs Specialist--Remote

Senior Regulatory Affairs Specialist / Regulatory Affairs Manager (994)

Senior Manager, Regulatory Affairs, Operations

Global Regulatory Affairs Chief of Staff

Regulatory Affairs and Compliance Manager

Regulatory Affairs CMC Specialist - Contract

Senior Regulatory Affairs Specialist Medical Device

Boston, MA $135,000.00-$165,000.00 1 month ago

Lincoln, RI $135,000.00-$165,000.00 1 month ago

Senior Regulatory Affairs Specialist / Regulatory Affairs Manager

Associate Director, Global Regulatory Affairs

Manager, Global Regulatory Affairs, Marketed Products

Boston, MA $111,800.00-$175,670.00 1 day ago

Senior Manager, Regulatory Affairs - Biologics

Boston, MA $165,000.00-$200,000.00 5 days ago

Associate Director CMC Regulatory Affairs

Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr