Manager, Regulatory Affairs

Verathon, Inc.•Bothell, WA

1d•$116,581 - $163,567•Hybrid

About The Position

Verathon® is looking for a Manager, Regulatory Affairs to join their Regulatory Affairs and Quality Assurance Team. This hybrid onsite role is responsible for leading the Regulatory Affairs function, managing the team to obtain and maintain market authorizations for Verathon’s global device portfolio. The role serves as the primary regulatory owner for FDA 510(k) submissions and global registration activities, providing strategic oversight, technical review, and team development. This position collaborates with Engineering, Clinical Affairs, Quality, and Commercial teams and reports to the Director of Regulatory Affairs.

Requirements

Bachelor’s degree in a scientific or engineering discipline (or equivalent experience).
3 to 5+ years of direct people management experience and 8+ years of regulatory experience with a regulated quality environment.
8+ years of related experience within a regulated quality environment, including people management.
Demonstrated experience preparing and managing traditional 510(k)s independently, including substantial equivalence argumentation, performance testing summaries, and FDA deficiency responses.
Working knowledge of FDA 21 CFR Part 807, 820, 801, and applicable FDA guidance documents (De Novo, Special 510(k), Predetermined Change Control Plans).
Experience with FDA eSTAR submission format.
Frequent interaction with external stakeholders, including FDA reviewers, Notified Body auditors, and international distributors, is a core expectation of this role.
Must be a critical thinker, detailed oriented with strong, structured, critical thinking skills, able to oversee multiple tasks for several projects or base business deliverables and effectively balance priorities.
Must have desire to work in a highly collaborative, productive, and empowered team environment.

Nice To Haves

Preferred direct experience with EU MDR Technical File preparation, Notified Body interactions, and EUDAMED registration workflows.
Preferred RAC certification.

Responsibilities

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.
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, 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.
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.
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 escalate 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 advise senior leadership on regulatory risk affecting business objectives.