Senior Regulatory Affairs Manager

Position SummaryThe Senior Manager, Regulatory Affairs will own and drive all regulatory activities across the product lifecycle for our regulated products portfolio. The role will ensure compliance with U.S. regulations (e.g., 21 CFR Part 820) and global standards (e.g., ISO 13485, ISO 14971), support future expansion into international markets and higher classification devices, and serve as a strategic regulatory partner to senior leadership. This person must be self-motivated, comfortable working in a lean environment, and able to set up processes as the company scales.Key ResponsibilitiesRegulatory StrategyAssess the US regulatory impact of changes, including product classification, submissions (i.e. 510k), labeling, and product claimsDevelop regulatory strategies for market expansion of products beyond the US, including device classifications, market access, and submission routes for new and legacy devicesProvide regulatory guidance to cross-functional teams throughout new product developmentConduct regulatory due diligence for Mergers & AcquisitionsRegulatory OperationsMaintain US FDA device and drug registrations and listings for medical devices, drugs, and biologics, for ASP and as US Agent for designated contract manufacturersEnsure compliance to UDI requirements, including maintenance of GUDID and other global UDI databasesMonitor and interpret global regulatory and standard changes and advise the organization on required actions.Review and approve device labeling, packaging, advertising, promotional materials, claims and instructions for useSupport Trade Compliance with FDA inquiries for timely importation of products.Support certification efforts and external auditsRegulatory SubmissionsPrepare and submit regulatory dossiers globally to support business objectives, including 510(k)’s, Canadian MDL’s, EU Tech Docs/DoC’s, amendments, supplements, and other global submissionsCoordinate responses to regulatory authorities (i.e. FDA, Health Canada, Notified Bodies, Competent Authorities, other health authorities) and manage liaison interactions.Maintain accurate regulatory documentation, records, and submission trackingPost-Market SurveillanceOversee post-market regulatory activities: complaint handling, vigilance/adverse event reporting, field corrective actions/recalls, health hazard evaluations, trend analysis, product surveillance.Leadership & CollaborationLead and mentor the regulatory affairs function — hire/integrate team as needed, define roles and responsibilities, foster a culture of excellence and continuous improvement.Serve as the primary regulatory contact for regulatory agencies, notified bodies and customers.Work cross-functionally with R&D, operations, marketing, sourcing, and procurement to enable regulatory alignment with business objectives.