The Judge Group
Sr Regulatory Affairs Specialist (Medical Device)
The Judge Group, Framingham, Massachusetts, us, 01704
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:
jgood@
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 Employment type
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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:
jgood@
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
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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
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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