Regulatory Affairs Director

Director of Regulatory Affairs

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. Relocation assistance is available for qualifying candidates.

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.

Required Knowledge & Expertise

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) and management (typically 7+ years) within pharmaceuticals, biotechnology, medical devices, or related industries, preferably with some focus on external partnerships.

Nice to Have

Working Conditions

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles : While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD) : $186,400.00 - $279,600.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). This position is eligible for an annual long-term incentive plan. The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification / education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week : 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).

The following benefits and additional compensation are available to all regular employees : 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).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below :

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and / or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you