We anticipate the application window for this opening will close on - 2 Jun 2026

 

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.

A Day in the Life

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.

         

         

Responsibilities may include the following and other duties may be assigned.

Regulatory Strategy Leadership

• 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.

Organizational and Team Leadership

• 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.

Regulatory Agency Engagement

• 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.

Cross-Functional Collaboration and Governance

• 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.

Operational Excellence and Business Alignment

• 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.

Required Knowledge and Experience:

• 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.

Nice to Have:

• 10+ years of medical device regulatory affairs experience
• Significant experience in medical device regulatory affairs supporting global product development and commercialization.
• Strong knowl