Sr Regulatory Affairs Specialist (Medical Device) Job at The Judge Group, Framingham, MA

RGhWUzkvNHd4dXZtVFIybWJTQWlUM1JjaUE9PQ==
  • The Judge Group
  • Framingham, MA

Job 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
The Judge Group

Job Tags

Permanent employment,

Similar Jobs

A Plus Electrical Contractors Llc

Electrician Helper/Apprentice Job at A Plus Electrical Contractors Llc

 ...Job Description Job Description A+ Electrical Contractors is looking for motivated electrician's helper/apprentice with basic hand tools, a valid driver's license, dependable transportation, and willingness to learn. A+ Electrical Contractors has an opportunity for... 

DLP Services

Environmental Safety Manager Job at DLP Services

 ...of: POSITION TITLE: Environmental Safety Manager Location: Charleston, South Carolina...  ...Manager establishes and oversees the health and safety processes for the...  ...Environmental Protection Agency (EPA) and Occupational Safety/Health Administration (OSHA) Regulations... 

Kaiser Permanente

Environmental Health and Safety Specialist III Job at Kaiser Permanente

 ...compliance with applicable federal, state, and local Environmental Health and Safety (EH&S) regulatory requirements, and organizational EH&S and...  ...[TJC], Environmental Protection Agency [EPA], Division of Occupational Health and Safety [DOHS], Occupational Safety and Health... 

MBC Talent Connections

Quality Assurance Manager Job at MBC Talent Connections

 ...Quality Assurance Manager (BILINGUAL NEEDED Spanish/ English) Job Overview: One of our leading Food Manufacturing clientsis seeking a highly skilled and experienced Quality Assurance Manager in Sherburne, New York. The ideal candidatewill be responsible for... 

Delaware Nation Industries

PC Technician Job at Delaware Nation Industries

 ...Delaware Nation Investments is seeking a highly qualified PC Technician for the Special Operation Command Information Technology Enterprise Contract (SITEC 3) Enterprise Operations and Maintenance (EOM). This role is located onsite at Fort Bragg. The purpose of the...