Senior Regulatory Affairs Specialist (Medical Devices)

Integrated Resources, Inc ( IRI ); Chaska (MN); Vor Ort; USD 110.000 - 170.000; Vollzeit

Zusammenfassung

Integrated Resources, Inc (IRI) seeks a Senior Regulatory Affairs Specialist to lead evaluation, coordination, and execution of post‑market regulatory activities for medical devices in the United States and globally. The role emphasizes adherence to corporate regulatory requirements and cross‑functional collaboration.

The ideal candidate will have a strong background in regulatory submissions (510(k), PMA) and experience guiding pre-market activities.

Qualifikationen

• Bachelor’s degree in field with 5+ years exp.
• Master’s degree in field with 3+ years exp.
• Medical Technologist background strongly desired.

Aufgaben

• Administer the company's complaint management program to ensure compliance with corporate requirements.
• Plan and implement pre-market registration, reporting and compliance activities per development center business plans.
• Implement global regulatory compliance programs for product corrective action and/or adverse event reporting.
• Prepare premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments.
• Assist technical departments, manufacturing centers and suppliers in creating and structuring clinical data for pre-market notifications.
• Serve as a team expert for review of promotional materials, experimental designs, data analysis and labeling related to registration and commercialization of medical devices.

Ausbildung

Bachelor’s degree in field

Master’s degree in field

Medical Technologist background

Jobbeschreibung

Integrated Resources, Inc (IRI) seeks a Senior Regulatory Affairs Specialist to lead evaluation, coordination, and execution of post‑market regulatory activities for medical devices in the United States and globally. The role emphasizes adherence to corporate regulatory requirements and cross‑functional collaboration.

The ideal candidate will have a strong background in regulatory submissions (510(k), PMA) and experience guiding pre-market activities.