Global Regulatory Affairs Manager - 510(k) & Strategy

Verathon, Inc.; Bothell (WA); Hybrid; USD 116,581 - 163,567; Full time

Benefits offered by this job

Medical insurance

Dental

Vision

401(k)

Paid holidays

Job summary

Verathon seeks a Manager, Regulatory Affairs to lead the Regulatory Affairs and Quality Assurance Team from its Bothell, WA headquarters. This hybrid onsite role focuses on FDA 510(k) submissions, global registrations, and regulatory strategy across the device portfolio.

You will mentor Regulatory Affairs Specialists, manage budgets, and collaborate with Engineering, Clinical, and Commercial teams to ensure timely market authorizations and compliance. Up to 10% travel required.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline (or equivalent).
• 8+ years regulatory experience in a regulated quality environment.
• 3 to 5+ years of direct people management experience.
• Experience with FDA 510(k) submissions and substantial equivalence.
• Working knowledge of FDA CFR parts 807, 820, 801 and related guidance.
• Experience with EU MDR Technical File preparation and Notified Body interactions.
• RAC certification preferred.
• Strong written and verbal communication with external stakeholders.

Responsibilities

• Own end-to-end FDA 510(k) submissions across product lines.
• Lead team development and manage Regulatory Affairs Specialists.
• Coordinate global registration activities and labeling requirements.
• Ensure regulatory activities are documented per QMS and support audits.
• Advise leadership on regulatory risk and strategy.

Skills

510(k) submissions

Regulatory strategy

Team leadership

FDA interaction

Education

Bachelor’s degree in science or engineering

RAC certification

Tools

eSTAR submissions

Notified Body coordination

Job description

Verathon seeks a Manager, Regulatory Affairs to lead the Regulatory Affairs and Quality Assurance Team from its Bothell, WA headquarters. This hybrid onsite role focuses on FDA 510(k) submissions, global registrations, and regulatory strategy across the device portfolio.

You will mentor Regulatory Affairs Specialists, manage budgets, and collaborate with Engineering, Clinical, and Commercial teams to ensure timely market authorizations and compliance. Up to 10% travel required.