Direct Hire SR Manager Regulatory Affairs

Senior Manager Regulatory Affairs | Salary Range: $128,000 - $145,000 + 15% bonus | Hybrid (3 days a week) | Full benefits, Medical, Dental, Vision, 401k – 4% match, Flex PTO Position Summary The Senior manager, Regulatory Affairs is responsible for developing and executing regulatory strategies for assigned product portfolios and projects across North America (US and Canada). This role leads the planning, preparation, and submission of regulatory filings (e.g., Pre-Submissions, 510(k)s, PMAs, PMA Annual Reports, IDEs, and License Applications) and serves as a key regulatory partner to cross-functional teams. The Senior Manager provides strategic regulatory guidance to support product development, commercialization, and lifecycle management while ensuring compliance with FDA and Health Canada requirements. This role collaborates closely with global regulatory counterparts within the Company's Group and may supervise regulatory staff and/or lead complex regulatory projects. Job Responsibilities Develop and execute regulatory strategies for assigned products and projects in alignment with North America and global regulatory objectives Lead the planning, preparation, and submission of regulatory submissions (e.g., Pre-Submissions, 510(k)s, PMAs, IDEs, and Health Canada License Applications) to support product approvals and lifecycle management Serve as the NAM regulatory representative on cross-functional project teams, providing guidance on regulatory requirements, risks, and timelines Lead interactions with FDA and Health Canada reviewers for assigned submissions, including responding to questions and managing communications in alignment with leadership Assess the regulatory impact of product changes and define appropriate regulatory pathways and documentation strategies Review and approve regulatory documentation, including submissions, Memos-to-File, labeling, and promotional materials to ensure compliance with applicable regulations Partner with global regulatory teams to ensure alignment on regulatory strategies, submissions, and change management activities Monitor evolving regulatory requirements, guidance documents, and industry trends to inform regulatory strategy and maintain compliance Contribute to regulatory intelligence activities, including competitive landscape assessments and interpretation of new regulations and standards Support regulatory operations activities as needed, including establishment registrations, device listings, and import/export compliance Manage the regulatory release of new products and address any regulatory import/export issues. Ensure regulatory deliverables are completed in accordance with project timelines and quality expectations Identify risks and proactively propose mitigation strategies to support successful regulatory outcomes Monitor for and lead opportunities with FDA and Health Canada to participate in relevant pilot programs and Experiential Learning Programs. May represent Regulatory Affairs in internal audits and support external inspections as needed Mentor junior regulatory staff and contribute to building regulatory capabilities within the organization Develop and monitor appropriate metrics to track regulatory and process improvement. Develop and deliver training regarding NAM Regulatory Affairs activities for Company Group globally and support cross-country projects as needed. Other duties as assigned. Management Responsibilities Direct: 1 to 3 Regulatory Affairs Specialists Physical Attributes General office environment. May sit for extended periods of time. Physically able to bend, crouch and reach continuously while performing required job tasks. Utilize dexterity abilities to perform typing, operate a computer and other office equipment, to perform filing, and related job responsibilities and attention to detail competence. Physically able to spend significant time reading both on paper and on a computer. Travel less than 5% both domestically and internationally. Minimum Qualifications Bachelor's Degree in a scientific, engineering, or related discipline. 7-10 years of experience in a medical technology company with regulatory, quality, or clinical experience. 5+ years of people management or demonstrated team leadership experience Preferred Qualifications Experience developing regulatory strategies and leading FDA and Health Canada submissions for all device classes Strong working knowledge of FDA and Health Canada regulation and guidance Experience negotiating and interfacing with FDA and Health Canada Strong project management and organizational skills with the ability to manage multiple priorities Excellent written and verbal presentation skills. Strong analytical and problem solving skills with a solutions-oriented mindset. Experience across multiple device types (e.g., capital equipment, consumables, implants, software as a medical device, etc.) Equal Opportunity Employer / Veterans / Disabled. Military connected talent encouraged to apply. The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act, Los Angeles City Fair Chance Ordinance, Los Angeles County Fair Chance Ordinance for Employers, San Francisco Fair Chance Ordinance. Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr