Regulatory Affairs Specialist - Senior
Listed on 2026-10-16
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Healthcare
Healthcare Compliance, Medical Science Liaison
The Fountain Group is currently seeking a Regulatory Affairs Specialist – Senior for a prominent client of ours. This position is located at Chaska, MN.Details for the position are as follows:
Job Title:
Regulatory Affairs Specialist – Senior
Location:
Chaska, MN
Pay Rate: $45–$52/hr
Duration: 1-year contract, with high potential for extension
Shift: Normal
Coordinate and execute post-market regulatory affairs activities for medical devices and in vitro diagnostics (IVD).
Administer complaint management programs to ensure compliance with corporate and regulatory requirements.
Plan and implement premarket registrations, regulatory reporting, and compliance activities.
Implement global regulatory programs for product corrective actions and adverse event reporting.
Prepare and coordinate regulatory submissions, including 510(k), PMA, and Technical Dossiers, for US and international markets.
Support technical, manufacturing, and supplier teams in preparing and structuring clinical data for premarket notifications.
Review promotional materials, experimental designs, data analysis, and product labeling for regulatory compliance.
Support medical device registration, commercialization, and ongoing regulatory compliance.
Bachelor’s degree in a relevant scientific or technical field with 5+ years of experience, or
Master’s degree in a relevant field with 3+ years of experience.
Medical Technologist background and IVD experience strongly preferred.
Regulatory Affairs experience in the medical device or IVD industry.
Post-market regulatory compliance and complaint management.
Premarket registration, regulatory reporting, and compliance activities.
Global corrective action and adverse event reporting.
Regulatory submissions, including 510(k), PMA, and Technical Dossiers.
Medical device labeling review and regulatory documentation.
Clinical data review and support for premarket notifications.
Medical Technologist or clinical laboratory background.
In vitro diagnostics (IVD) regulatory experience.
US and international medical device registration.
Promotional materials review and product commercialization.
Experience with experimental design and regulatory data analysis
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