Sr Prin Regulatory Affairs Spec

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.

About the role

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 workstreams, 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

• 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.

Requirements

• Bachelors degree required.
• Minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience.
• 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.

Nice to Have

• Experience with FDA pre-determined change control plan (PCCP) submissions.
• Clinical trial submissions.
• Regulatory review of advertising and promotion materials.

Physical Job Requirements

The physical demands described 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.

U.S. Work Authorization & Sponsorship

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 Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Pay

Salary ranges for U.S (excl. PR) locations (USD): $157,600.00 - $236,400.00

United Kingdom: 87,280.00 GBP - 130,920.00 GBP

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). 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.

Benefits

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
• 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)
• 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.