Manager, Regulatory Affairs

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. 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. Manage, mentor, and develop a team of Regulatory Affairs Specialists, setting clear performance expectations, conducting regular 1:1s, and supporting professional growth. Author and maintain regulatory SOPs, work instructions, and Letter to File assessments within Verathon's QMS. Ensure regulatory activities 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.