Sr Regulatory Affairs Manager
About The Position
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. The Senior Manager, Regulatory Affairs is responsible for leading the development and execution of global regulatory strategies to support worldwide product approvals and lifecycle management for the Acute Care and Monitoring (ACM) Shiley™ airway product portfolio. This role provides strategic leadership for regulatory activities supporting product development, commercialization, and post-market compliance, with particular focus on the US and EU and supports to rest of the world. The Senior Manager leads a team of regulatory professionals and works across a highly matrixed organization to develop and align regulatory strategies with business objectives. This role partners closely with R&D, Quality, Clinical, Marketing, and Operations to ensure regulatory requirements are effectively integrated into product development and lifecycle management activities. The ACM Operating Unit is committed to excellence in innovation and commercialization to advance our vision and long-term business growth. The ACM operating unit is evolving its product delivery, innovation, and commercialization approaches to strengthen product leadership across the portfolio and enable product development excellence across ACM. This position requires onsite presence four(4) days per week at our Lafayette, Colorado location.
Requirements
- Bachelor’s Degree with and minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Nice To Haves
- 10+ years of medical device regulatory affairs experience
- Significant experience in medical device regulatory affairs supporting global product development and commercialization.
- Strong knowledge of U.S., EU, and international regulatory requirements, including EU MDR.
- Experience leading interactions with US FDA and other regulatory agencies, including regulatory meetings and submission strategy discussions.
- Demonstrated ability to lead cross-functional initiatives within a complex, matrixed organization.
- Proven track record of leading high‑performing regulatory teams
- Strong communication, strategic thinking, and decision-making skills.
Responsibilities
- Lead the development and execution of global regulatory strategies supporting new product development, product modifications, and lifecycle management across the ACM Shiley™ airway product portfolio.
- Provide strategic regulatory guidance to cross-functional teams to support business objectives and enable successful product commercialization.
- Anticipate regulatory risks and develop mitigation strategies to support timely approvals and market access.
- Ensure regulatory considerations are integrated into product development, clinical, and commercialization strategies.
- Lead, develop, and mentor a team of regulatory professionals responsible for global regulatory activities.
- Establish clear objectives, provide coaching and feedback, and foster a high-performance and accountable team culture.
- Identify and develop key talent while supporting career development across all levels of the organization.
- Promote a safe, inclusive, and collaborative work environment.
- Provide leadership for interactions with the US FDA and EU Notify Body related to regulatory strategy and submission reviews.
- Guide the submission strategy development, preparation, and review of regulatory submissions and ensure high-quality regulatory documentation.
- Support regulatory agency meetings and negotiations to facilitate product approvals.
- Partner with R&D, Quality, Clinical, Marketing, and Operations to ensure regulatory alignment across product programs and lifecycle activities.
- Provide regulatory leadership for new product registrations, product modifications, technology transfers, and acquisition activities.
- Ensure compliance with applicable global regulatory requirements and standards, including U.S. FDA regulations and EU MDR.
- Provide regulatory input to labeling, promotional review, manufacturing changes, and clinical activities to ensure compliance.
- Monitor regulatory progress against program milestones and provide updates to senior leadership.
- Drive continuous improvement of regulatory processes, tools, and communication pathways.
- Ensure effective planning and prioritization of regulatory activities across the team to support business objectives.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
