Director, AI Medical Device Regulatory Affairs

Meet Life Sciences Ltd.; United States; Vor Ort; USD 140.000 - 200.000; Vollzeit

Zusammenfassung

Meet Life Sciences Ltd. is seeking a Regulatory Affairs Manager/Director to lead FDA submissions, clinical validation and regulatory strategy for AI-enabled medical devices.

This role collaborates closely with Clinical, R&D and Quality teams to drive regulatory excellence. You will manage 510(k) submissions, respond to FDA inquiries, and shape regulatory pathways while ensuring robust data integration and risk management across programs.

Qualifikationen

• 5+ years' experience in Regulatory Affairs and 8+ years' overall industry experience.
• Hands-on experience with AI-enabled medical devices.
• Experience with reader studies / clinical validation is highly desirable.

Aufgaben

• Lead and coordinate US FDA regulatory submissions, including 510(k)s and pre-submissions.
• Prepare responses to FDA questions and requests for additional information.
• Coordinate regulatory activities across cross-functional teams (R&D, Clinical Affairs, Quality).
• Gather and integrate data for regulatory submissions with Clinical and R&D inputs.
• Support clinical evidence generation and validation activities for AI-enabled devices.
• Contribute to regulatory strategy for clinical validation, product development and post-market activities.
• Support risk management activities and CAPA processes.
• Assist with audits, inspections and regulatory inquiries.
• Review and approve materials intended for regulatory submissions.

Kenntnisse

FDA submissions

Regulatory strategy

Clinical validation studies

AI medical devices

Reader studies

Cross-functional collaboration

Regulatory risk management

Regulatory inspections

Documentation & submissions

Project management

Ausbildung

Bachelor's or Master's in Medical Technology, Life Sciences or related

Jobbeschreibung

Meet Life Sciences Ltd. is seeking a Regulatory Affairs Manager/Director to lead FDA submissions, clinical validation and regulatory strategy for AI-enabled medical devices.

This role collaborates closely with Clinical, R&D and Quality teams to drive regulatory excellence. You will manage 510(k) submissions, respond to FDA inquiries, and shape regulatory pathways while ensuring robust data integration and risk management across programs.