Regulatory Affairs Director

Medtronic • Lafayette, CO

2d • Onsite

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. A Day in the Life As the Director of Regulatory Affairs, you are a critical leader and the ultimate regulatory authority within the Acute Care & Monitoring (ACM) operating unit for the product portfolio within your scope. Your day is focused on setting strategic direction, managing a portfolio of high-impact devices, and delivering excellence through a world-class team. A significant part of your day is dedicated to mentorship and talent development, ensuring your team has the resources and guidance they need to excel. You will work closely with other leaders to align regulatory strategy with enterprise-wide goals, such as market expansion, product innovation, and M&A activities. You'll also dedicate time to external engagement, representing the company in discussions with regulatory bodies, industry associations, and at conferences. Your role is not just about compliance; it's about leveraging regulatory expertise as a competitive advantage to drive business success. This role is an on-site position based at our Lafayette, CO office.

Requirements

• Strategic Leadership: Proven experience in a senior leadership role, with a track record of building and managing high-performing teams and departmental strategy.
• Regulatory Affairs: Deep and comprehensive knowledge of the global regulatory landscape and a proven history of successful interactions with regulatory bodies.
• Product Lifecycle: Experience with advancing medical devices from concept to market approvals, post-market monitoring, and eventual discontinuation.
• Business Acumen: Exceptional financial management skills, including strategic budget planning, and a strong understanding of business operations and corporate finance.
• Process Excellence: Demonstrated expertise in driving large-scale, enterprise-wide process improvements and change management.
• Data & Analytics: Ability to leverage data and analytics to inform strategic decisions and communicate complex information to executive stakeholders.
• Communication & Influence: Superior communication, negotiation, and influencing skills, with the ability to operate at an executive level and represent the company externally.
• Minimum Qualifications: Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
• Extensive experience in regulatory affairs (typically 10+ years)
• Experience as a people manager managing large teams (typically 7+ years) within pharmaceuticals, biotechnology, medical devices, or related industries, preferably with some focus on external partnerships.

Nice To Haves

• Proven track record of successful regulatory leadership in managing external collaborations and partnerships.
• In-depth knowledge of global regulatory requirements and standards in the patient monitoring and respiratory spaces.
• Ability to travel domestically and internationally as required.
• Willingness to work outside of normal working hours to accommodate communication with global partners.
• Proficiency in regulatory software applications and databases.

Responsibilities

• Regulatory Strategy & Product Development: Develop and implement global regulatory strategies to support the entire product lifecycle, from R&D through to commercialization and post-market activities.
• Partner with R&D, clinical, operations, and marketing teams to ensure regulatory requirements are embedded into product development plans and timelines.
• Provide expert guidance on regulatory pathways, including expedited programs, for new product submissions (e.g., 510(k), etc.).
• Market Access & Submissions: Lead and oversee the preparation, review, and submission of regulatory filings in the US and EU.
• Directly engage with regulatory bodies (e.g., FDA, Notified Body) to negotiate approvals and resolve complex regulatory issues.
• Team Leadership & Development: Direct the allocation of resources to a portfolio of product programs, ensuring alignment with corporate priorities and maximizing return on investment.
• Make key decisions on team structure, talent acquisition, and professional development to build a high-performing and scalable organization.
• Mentor and coach senior regulatory affairs managers to enhance their skills and foster future leaders.
• Risk Management & Compliance: Serve as the senior-most authority on regulatory risk, identifying potential issues and developing mitigation strategies.
• Stay abreast of evolving regulatory trends, guidelines, and changes, providing proactive regulatory guidance.
• Other Business Initiatives: Serve as a key strategic advisor for major business initiatives and lead due diligence for regulatory risks and opportunities associated with new ventures and partnerships.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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, and 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees