Regulatory Affairs Manager: 510(k) & Global Strategy

Verathon; Bothell (WA); Hybrid; USD 116.581 - 163.567; Vollzeit

Zusammenfassung

Verathon is seeking a Manager, Regulatory Affairs at our Bothell, WA headquarters. This hybrid onsite role leads Regulatory Affairs, overseeing FDA 510(k) submissions and global registrations, and shaping regulatory strategy across Engineering, Clinical Affairs, Quality and Commercial teams.

You will mentor a team of Regulatory Affairs Specialists, manage budgets, and ensure compliance within the QMS, while coordinating with distributors and regulators. Travel up to 10% internationally.

Qualifikationen

• Bachelor’s degree in a scientific or engineering discipline.
• 8+ years regulatory experience with a regulated quality environment; 3+ years in people management.
• Direct experience preparing and managing traditional FDA 510(k) submissions.
• Working knowledge of FDA 21 CFR Parts 807, 820, 801 and related guidance.
• Experience with FDA eSTAR submission format.
• Preferred: EU MDR Technical File prep and Notified Body interactions.
• Up to 10% international travel.

Aufgaben

• 510(k) strategy and submissions.
• Own end-to-end lifecycle of FDA 510(k) submissions.
• Lead preparation of summaries and supporting docs.
• Lead response strategy for FDA requests and deficiency letters.
• Evaluate eligibility for Traditional, Abbreviated, and Special 510(k) pathways.
• Maintain awareness of evolving FDA guidance and De Novo precedents.
• Global Registration Management.
• Oversee international registration activities across markets.
• Manage registration timelines, distributor relationships, and country-specific documentation.
• Ensure post-market registration maintenance including renewals and market expansions.

Kenntnisse

Regulatory leadership

FDA submissions

510(k) expertise

Team management

Ausbildung

Bachelor’s degree in Science or Engineering

Jobbeschreibung

Verathon is seeking a Manager, Regulatory Affairs at our Bothell, WA headquarters. This hybrid onsite role leads Regulatory Affairs, overseeing FDA 510(k) submissions and global registrations, and shaping regulatory strategy across Engineering, Clinical Affairs, Quality and Commercial teams.

You will mentor a team of Regulatory Affairs Specialists, manage budgets, and ensure compliance within the QMS, while coordinating with distributors and regulators. Travel up to 10% internationally.