Regulatory Affairs Specialist - Medical Device

SRG; Boston (MA); Remote; USD 125,000 - 150,000; Full time

Job summary

A leading company in Life Sciences seeks a Regulatory Affairs Specialist for a fully remote role. The ideal candidate will have experience in Medical Devices and be responsible for preparing EU MDR technical documentation. Join a diverse team committed to inclusion.

Qualifications

• 3-5 years of experience in regulated industries like Medical Devices, Biotech, or Pharma.

Responsibilities

• Lead MDR remediation efforts.
• Assist project teams with technical documentation and standards.
• Prepare and submit EU MDR technical documentation.

Skills

Medical device experience

French language skills

Education

Bachelor's degree in Science

Bachelor's degree in Engineering

Bachelor's degree in Regulatory Affairs

Job description

Regulatory Affairs Specialist - Medical Device

Join to apply for the Regulatory Affairs Specialist - Medical Device role at SRG.

This is a full-time, contract, fully remote position within the Medical Device Manufacturing Team. Medical device experience is required.

Base pay range

$56.00/hr - $56.00/hr

Job overview

SRG, a leader in the Life Sciences human capital industry, seeks a Regulatory Affairs Specialist with 3-5 years of experience in regulated industries such as Medical Devices, Biotech, or Pharma. The role involves preparing and submitting EU MDR technical documentation, guiding project teams on regulatory requirements, and collaborating with Notified Bodies.

Must-have qualifications

• Bachelor's degree in Science, Engineering, Regulatory Affairs, or related field
• Experience with EU MDR submissions for Class II and III devices
• Knowledge of IEC 60601 / IE 62304 standards
• French language skills (not required to be fluent)

Key responsibilities

• Lead MDR remediation efforts
• Assist project teams with technical documentation and standards
• Coordinate with Notified Bodies during certification processes
• Prepare and submit EU MDR technical documentation for various device classes

Note: Only candidates selected for next steps will be contacted. SRG is committed to diversity and inclusion and provides accommodations for applicants with disabilities.