Senior Regulatory Affairs Manager (60716)

Position Summary

The 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 Responsibilities

Regulatory Strategy

• Assess the US regulatory impact of changes, including product classification, submissions (i.e. 510k), labeling, and product claims
• Develop regulatory strategies for market expansion of products beyond the US, including device classifications, market access, and submission routes for new and legacy devices
• Provide regulatory guidance to cross-functional teams throughout new product development
• Conduct regulatory due diligence for Mergers & Acquisitions

Regulatory Operations

• Maintain US FDA device and drug registrations and listings for medical devices, drugs, and biologics, for ASP and as US Agent for designated contract manufacturers
• Ensure compliance to UDI requirements, including maintenance of GUDID and other global UDI databases
• Monitor 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 use
• Support Trade Compliance with FDA inquiries for timely importation of products.
• Support certification efforts and external audits

Regulatory Submissions

• Prepare 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 submissions
• Coordinate 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 tracking

Post-Market Surveillance

• Oversee post-market regulatory activities: complaint handling, vigilance/adverse event reporting, field corrective actions/recalls, health hazard evaluations, trend analysis, product surveillance.

Leadership & Collaboration

• Lead 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.

Minimum Qualifications

• Bachelor’s degree in a scientific, engineering, regulatory or related field; advanced degree preferred
• Minimum 5 years of regulatory affairs experience in the medical device industry
• Experience with FDA Class I devices
• Proven expertise in FDA medical-device regulations (21 CFR Part 820) and a sound understanding of global regulatory frameworks
• Knowledge of ISO 13485 and ISO 14971
• Experience interacting with regulatory authorities (e.g., FDA, Health Canada, notified bodies)
• Excellent communication, leadership, strategic thinking and problem-solving skills
• Self-motivated, able to work independently in a fast-paced / growing environment, comfortable setting up processes and managing ambiguity

Preferred Skills

• RAPS Regulatory Affairs Certification (RAC)
• Experience with medical-device post-market surveillance practices
• Experience with FDA Class II, Canada Class I-III, and EU Class I-II devices
• Experience preparing for MDSAP/ISO 13485 audits and presenting to external auditors
• Preparation and submission of 510(k)’s, Canadian MDL’s, and EU Tech Docs/DoC’s