Senior Regulatory Affairs Manager

We anticipate the application window for this opening will close on - 22 Jul 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

This position sits within the Regulatory Affairs Data and Product Release group in the Medtronic Clinical & Regulatory Solutions (MCRS) organization and leads the global Product Release team. The role is responsible for providing strategic direction and people leadership, coaching and developing managers and teams to deliver timely, accurate, and compliant product releases in support of global market access. A role within MCRS offers a unique opportunity to be part of a global, high-impact team, collaborating across functions, gaining visibility into enterprise-wide structures, and contributing to initiatives that drive meaningful impact across Medtronic.

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.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Open to candidates based at Medtronic locations across the U.S.

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

* Lead and develop a high-performing team focused on product release and regulatory execution

* Lead end-to-end regulatory product release strategy and execution, ensuring compliance with global regulatory requirements

* Drive process standardization, simplification, and automation across product release workflows

* Lead data quality initiatives to support compliant global submissions and product distribution

* Oversee regulatory distribution control processes (e.g., GTS/SAP) to enable timely and accurate product release

* Lead continuous improvement initiatives focused on cycle time, quality, and scalability of release processes

* Establish and monitor KPIs, dashboards, and reporting to track performance and compliance

* Build organizational capability in regulatory systems, data, and operational execution

Minimum Requirements

* Bachelor's degree

* 7+ years of experience supporting or leading product release, distribution control, or regulatory operations processes (or 5+ years with advanced degree)

* 5+ years of managerial experience

* Strong knowledge of global regulatory requirements impacting product distribution (FDA, EU MDR, international markets)

Nice to Have

* Organizational skills and highly detail oriented

* Intermediate knowledge of spreadsheet and database applications (Microsoft Office, and SharePoint)

* Analytical and problem-solving skills

* Excellent communication skills

* Effective project management skills

* Experience with GTS/SAP, UDI (GUDID/EUDAMED), and/or RIM systems

* Experience in regulatory data management, governance, or digital transformation

* Experience driving process harmonization across global organizations

* Proven ability to work in complex, matrixed organizations and influence stakeholders

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.

Physical

Job Requirements

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.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide…