Manager, Regulatory Affairs

Company Overview

Verathon
is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company’s Bladder Scan portable ultrasound and Glide Scope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients.

Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. For more information, please

Verathon® is looking for a Manager, Regulatory Affairs to become the newest member of our Regulatory Affairs and Quality Assurance Team located in our Bothell, WA headquarters. This role is hybrid onsite.

The Manager, Regulatory Affairs leads the Regulatory Affairs function, managing the discipline through Regulatory Affairs Specialists and, as the team scales, subordinate supervisors responsible for obtaining and maintaining market authorizations across Verathon’s global device portfolio. This manager serves as the primary regulatory owner for FDA 510(k) submissions and global registration activities, providing strategic oversight, technical review, and team development. This role collaborates across Engineering, Clinical Affairs, Quality and Commercial teams.

This role reports to the Director of Regulatory Affairs.

• 510(k) Strategy and Submissions
  • Own the end-to-end lifecycle of FDA 510(k) submissions across Verathon’s product lines, including predicate selection, substantial equivalence argumentation, and eSTAR preparation.
  • Direct team preparation of 510(k) summaries, performance testing summaries, SE comparison tables, and supporting technical documentation.
  • Lead response strategy for FDA Additional Information requests and deficiency letters, coordinating cross-functional inputs under compressed timelines.
  • Evaluate eligibility for Traditional, Abbreviated, and Special 510(k) pathways and recommend the appropriate submission type based on device changes and applicable FDA guidance.
  • Maintain awareness of evolving FDA guidance and De Novo precedents affecting the device categories in Verathon’s portfolio.
• Global Registration Management
  • Oversee international registration activities across applicable global markets.
  • Manage registration timelines, distributor relationships, and country-specific documentation packages.
  • Ensure post-market registration maintenance activities including renewals, and Market expansions and Product Change Notifications (PCNs) are filed on schedule.
  • Coordinate with regional distributors and in-country agents to satisfy local labeling, language, and technical file requirements.
• Team Leadership and Development
  • Manage, mentor, and develop a team of Regulatory Affairs Specialists, setting clear performance expectations, conducting regular 1:1s, and supporting professional growth.
  • Assign and prioritize workloads across the team to align with submission timelines, regulatory milestones, and business objectives.
  • Build team capability in technical writing, standards interpretation, and regulatory strategy through structured coaching and training.
  • Partner with the Associate Director to identify staffing needs and contribute to workforce planning.
  • Own budget planning and tracking for the Regulatory Affairs function, including headcount planning and vendor and consultant spends.
• Quality System and Compliance
  • Author and maintain regulatory SOPs, work instructions, and Letter to File assessments within Verathon’s QMS.
  • Ensure regulatory activities and are documented and traceable per QMS requirements, supporting both internal audits, and Notified Body or MDSAP surveillance audits.
  • Identify and escape regulatory risks, and change assessment triggers in a timely manner.
  • Translate Regulatory Affairs functional plans into operational processes, contribute to annual regulatory strategy and planning, and…