Senior Regulatory Affairs Specialist – Medical Devices & IVD

The Fountain Group; Chaska (MN); On-site; USD 128,943,000 - 149,001,000; Full time

Job summary

The Fountain Group is seeking a Regulatory Affairs Specialist – Senior for a contract role in Chaska, MN. The position focuses on post-market regulatory activities, complaint management, and international regulatory submissions for medical devices and IVDs.

Ideal candidates hold a Bachelor’s or Master’s in a relevant field with substantial regulatory experience, including 510(k) and PMA. This 1-year contract offers competitive hourly pay and extension potential.

Qualifications

• Bachelor’s degree in a relevant field with 5+ years experience, or a Master’s with 3+ years.
• Medical Technologist background and IVD experience strongly preferred.
• Experience with 510(k), PMA, and Technical Dossiers.

Responsibilities

• Coordinate post-market regulatory activities for medical devices and IVD.
• Manage complaint programs to ensure regulatory compliance.
• Plan and implement premarket registrations and regulatory reporting.
• Execute global regulatory programs for corrective actions and adverse events.
• Prepare regulatory submissions for US and international markets.
• Support clinical data for premarket notifications.
• Review labeling, promo materials, and data analyses for compliance.
• Assist with registration and ongoing compliance of medical devices.

Skills

Regulatory affairs

Post-market compliance

Premarket registrations

Regulatory submissions

Medical device labeling

Clinical data review

Education

Bachelor's degree

Master's degree

Medical Technologist background

Job description

The Fountain Group is seeking a Regulatory Affairs Specialist – Senior for a contract role in Chaska, MN. The position focuses on post-market regulatory activities, complaint management, and international regulatory submissions for medical devices and IVDs.

Ideal candidates hold a Bachelor’s or Master’s in a relevant field with substantial regulatory experience, including 510(k) and PMA. This 1-year contract offers competitive hourly pay and extension potential.