Regulatory Affairs Specialist - Senior

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