Sr Prin Regulatory Affairs Spec

We anticipate the application window for this opening will close on - 17 Aug 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

The Senior Principal Regulatory Affairs Specialist will provide strategic regulatory leadership for multiple complex product development programs, with a particular focus on AI‑enabled technologies. This role is responsible for developing and executing global regulatory strategies, leading the planning, preparation, and submission of high‑quality regulatory filings, and ensuring alignment with evolving regulatory expectations for innovative digital and AI‑driven solutions. The individual will manage multiple work streams, collaborate closely with cross‑functional partners, and proactively identify and mitigate regulatory risks to support timely approvals and successful market access.

This position is intended for an experienced regulatory professional who can operate with a high degree of independence, while managing concurrent projects, influence strategy across programs, and help build long‑term regulatory capability within the organization.

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

* Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

* Leads or compiles all materials required in submissions, license renewal and annual registrations.

* Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

* Monitors and improves tracking / control systems.

* Keeps abreast of regulatory procedures and changes.

* May direct interaction with regulatory agencies on defined matters.

* Recommends strategies for earliest possible approvals of clinical trials applications.

* Experience in software, cybersecurity, and AI/ML related regulatory submissions.

Must Have:

Minimum Requirements

* Bachelors degree required

* Minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience.

Nice to Have

* Experience with FDA pre-determined change control plan (PCCP) submissions.

* Clinical trial submissions.

* Regulatory review of advertising and promotion materials.

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 workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the…