Sr. Principal Regulatory Affairs Strategy Specialist

Medtronic; Fridley (MN); On-site; USD 158,000 - 236,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

401(k) with employer match

Competitive benefits package

Job summary

Medtronic is seeking a Senior Regulatory Strategy Specialist to partner with Regulatory affairs across the organization, guiding complex regulatory questions for software-enabled medical devices and acquisitions.

You will influence enterprise regulatory practice, work closely with operating units, and support mergers, acquisitions, and integration projects while operating with significant independence onsite in the U.S.

Qualifications

• Experience developing or advising on global regulatory strategies for complex, high-risk, or novel technologies.
• Experience supporting medical device submissions and health authority interactions.
• Knowledge of software and AI-enabled medical devices regulatory considerations.

Responsibilities

• Partner regulatory teams to shape strategies for complex devices and market expansion.
• Advise on regulatory pathways, evidence, risk management and post-market commitments.
• Translate regulatory intelligence into practical guidance for leadership and cross-functional teams.

Skills

Regulatory strategy

Global regulatory

Software/regulatory alignment

Education

Bachelor's degree

Advanced degree

Job description

Onsite

Mounds View, Minnesota, United States of America

Fridley, Minnesota, United States of America

North Haven, Connecticut, United States of America

Lafayette, Colorado, United States of America

Full time

R76748

We anticipate the application window for this opening will close on - 2 Oct 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 Sr. Principal Regulatory Strategy Specialist is an individual contributor within Global Regulatory Affairs responsible for supporting and partnering with Regulatory teams across the organization as they shape and advance regulatory strategies aligned with Medtronic’s business goals and objectives. This role will partner closely with operating unit teams to provide additional expertise and guidance on complex, novel, and strategically important regulatory questions across the product lifecycle, including supporting effective due diligence for acquisitions. This role will help teams assess options, anticipate obstacles, and develop practical, risk-based pathways for innovative technologies across Medtronic, including but not limited to software-enabled products. The role will also provide consultation to operating unit teams involved in mergers, acquisitions, licensing, and integration activities across product portfolios.

This position is expected to operate with a high degree of independence, influence without direct authority, and convert insights into enterprise value through internal best practices and educational support for regulatory professionals and cross-functional partners. This is a unique opportunity to contribute across Medtronic’s diverse and cutting edge portfolio.

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.

LOCATION: The person in this role may work onsite at a US-based Medtronic facility.

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

• Partner with operating unit regulatory teams to help develop and refine strategies for complex medical devices, novel technologies, significant product changes, and market expansion opportunities.

• Provide strategic input on regulatory pathways, intended use, claims, evidence expectations, risk management, and post-market commitments.

• Support regulatory authority interactions by helping frame key questions, review briefing materials, contribute to response strategies, and communicate positions clearly and credibly.

• Advise on software and digital-health regulatory strategy, including software lifecycle expectations, AI-enabled functionality, interoperability, and connected systems.

• Serve as an enterprise advisor to operating unit regulatory teams conducting M&A, integration, or remediation activities by helping identify potential regulatory opportunities, risks, relevant internal process considerations, and applicable cross-portfolio precedent.

• Translate regulatory intelligence regarding evolving global regulations, guidance, policy, and deficiency trends into practical implications for Medtronic business regulatory strategies.

• Identify recurring strategic issues and deficiency trends across operating units to inform training content.

• Synthesize complex technical and regulatory issues into clear recommendations for senior leaders, regulatory teams, and cross-functional partners.

Must Have: Minimum Requirements

• Bachelor's degree

• 10+ years of related experience within the medical device industry or a regulatory agency (or 8+ years with an advanced degree)

Nice to Have (Preferred Qualifications)

• Experience developing or advising on global regulatory strategies, pathways, and evidence approaches for complex, high-risk, or novel technologies where precedent may be limited or evolving.

• Experience supporting medical device submissions and health authority interactions.

• Working knowledge of software and AI-enabled medical devices, including software lifecycle management, documentation, risk management, validation, maintenance, and change control.

• Experience providing regulatory input to teams involved in mergers, acquisitions, licensing, or integration activities.

• Direct experience working for a regulator, particularly in a scientific review role.

• Demonstrated ability to translate changing regulatory expectations into practical internal guidance or educational content.

• Strong analytical judgment, with the ability to balance business objectives, regulatory requirements, patient impact, and execution risk.

• Strong collaboration and influence skills, with the ability to build trust across businesses, functions, and geographies.

• Knowledge of product development, clinical strategy, quality systems, manufacturing, and postmarket requirements for medical devices.

• Advanced degree in a technical, scientific, or engineering area.

• RAC certification or similar credential is a plus.

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

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):$157,600.00 - $236,400.00

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. 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 that 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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

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 can find here (https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf) a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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.

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.

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees).

For updates on job applications, please go to the candidate login page and sign in to check your application status.

If you need assistance completing your application please email [e-mail]

To request removal of your personal information from our systems please email [e-mail]

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

• Build a better future, amplifying your impact on the causes that matter to you and the world

• Grow a career reflective of your passion and abilities

• Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning