Regulatory Affairs Specialist - Senior

The Fountain Group; Chaska (MN); Vor Ort; USD 128.943.000 - 149.001.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory affairs

Post-market compliance

Premarket registrations

Regulatory submissions

Medical device labeling

Clinical data review

Ausbildung

Bachelor's degree

Master's degree

Medical Technologist background

Jobbeschreibung

The Fountain Group iscurrently 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

Job Description

• 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.

Education

• 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.

Required Skills

• 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.

Preferred Skills

• 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