Job description

MDR Principal Regulatory Affairs Specialist needed to author RA submissions for cardiac rhythm devices. Strong experience with electromechanical devices is preferred and must have previous experience with authorship/remediation of EU MDR compliant technical files. The team is also requiring experience performing Post market maintenance and product change assessments for Class II and III devices.

Principal Regulatory Affairs Specialist (24 month contract // Mounds View, MN):

Top Skills:

• Strong experience with domestic and overseas submissions (PMA, 510(k), IDE, Technical Files, etc.) for Class II and III devices
• EU MDR remediation experience
• Post market maintenance and experience executing product impact assessments
• Specific experience with product change assessments for Class II, and III devices

Experience and Education:

• Requires a University Degree and minimum 7-10 years of submissions authorship experience, or advanced degree with a minimum of 6-7+ years of relevant experience.
• 5+ years of regulatory experience in the medical device, biotech, or pharmaceutical industry with Bachelor’s degree.
• Experience in regulatory submissions, including writing/developing/preparing submissions for complex medical devices (PMA, 510(k)), Investigational Device Exemption (IDE), EU technical files for Class IIa/IIb and design dossiers for Class III, PMA supplements

Job Types: Contract, Full-time

Pay: $60.00 - $90.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Regulatory: 5 years (Required)
• EU MDR: 3 years (Required)

Work Location: Remote

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