Principal Regulatory Affairs Specialist

Medtronic plc; United States; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health, dental and vision insurance

401(k) with employer contribution

Job summary

Medtronic in Lafayette, CO or Mounds View, MN seeks a Principal Regulatory Affairs Specialist to lead global regulatory strategies for the RST consumable portfolio. This high‑autonomy role partners with cross‑functional teams across early development, commercialization, and lifecycle activities, ensuring strategic alignment with business goals.

Responsibilities include directing US and EU submissions (510(k), PMA, IDE; EU Technical Documentation), guiding labeling changes, and mentoring staff,

Qualifications

• Bachelor's degree required.
• Minimum of 7 years of relevant experience, or 5+ with advanced degree.
• Extensive experience in medical device regulatory affairs.
• In-depth knowledge of EU MDR, ISO 13485, ISO 14971 and ISO 10993-1.
• Proven experience authoring and leading U.S. regulatory submissions.

Responsibilities

• Lead global regulatory strategies across product lifecycle.
• Provide input for early development pathways and data needs.
• Collaborate with R&D, marketing, clinical, operations and leadership.
• Serve as regulatory lead for advertising material review and compliance.
• Lead or oversee US and EU submissions and change notifications.
• Mentor junior regulatory staff and support agency interactions.

Skills

Regulatory affairs

Medical devices

EU MDR

US FDA submissions

ISO 13485

ISO 14971

Advertising & promotions reviews

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's degree

Job description

We anticipate the application window for this opening will close on - 19 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

This position is located in Lafayette, CO or Mounds View, MN and supports Robotics Surgery Technologies (RST) in the Surgical Operating Unit.

The Principal Regulatory Affairs Specialist (Pr. RAS) provides regulatory leadership and strategic direction for the consumable product [CB2.1]portfolio within RST. This role is responsible for collaborating with cross‑functional partners to develop, plan, and execute global regulatory strategies across early development, commercialization, lifecycle management, and business transition activities as well as supporting complex post‑market release and sustaining change activities. This position is suited for a high‑performing individual contributor who operates with a high degree of autonomy on moderately to highly complex programs. With limited supervision, the Pr. RAS sets objectives aligned with broader business and portfolio goals, drives regulatory strategy, and contributes to critical project and business milestones. The role requires strong awareness of cross‑functional and organizational initiatives and the ability to assess regulatory impact on business decisions. The Pr. RAS regularly communicates with internal stakeholders to provide strategic input, share updates, and support informed decision‑making. Serving as a regulatory subject matter expert and individually contributing leader, this role acts as a role model within the organization and may mentor or provide guidance to junior regulatory professionals or support staff as needed.

Position requires to be onsite 4 days per week in one of the following locations:

• Lafayette, CO
• Mounds View, MN

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

• Lead and execute global regulatory strategies across the product lifecycle, including early development and business wind‑down activities.
• Provide regulatory strategy input for early‑stage development, including pathway assessment, classification, and data requirements.
• Serve as a strategic partner to R&D, marketing, clinical, operations, and leadership to integrate regulatory considerations into product and business decisions.
• Act as regulatory lead for advertising and promotional material review, providing strategic guidance on claims, risk communication, and compliant promotional approaches.
• Lead or oversee preparation of U.S. and EU regulatory submissions, and support submissions for global markets.
• Recommend and guide changes to labeling, manufacturing, marketing, and clinical activities to ensure compliance and support business objectives.
• Monitor and interpret global regulatory requirements and changes, proactively communicating risks and opportunities to stakeholders.
• Support and lead regulatory agency interactions, audits, inspections, and CAPA activities, as appropriate.
• Develop and deliver regulatory training; mentor junior regulatory staff.

Must Have:

• Minimum Requirements
• Bachelor's degree required
• Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience
• Nice to Have
• Extensive experience in medical device regulatory affairs.
• Strong hands‑on experience with U.S. Class II and III medical devices, including applicable regulatory requirements and consensus standards.
• In‑depth knowledge of EU MDR, ISO 13485, ISO 14971 risk management principles, and ISO 10993‑1.
• Proven experience authoring and leading U.S. regulatory submissions (e.g., 510(k), PMA, IDE) and EU Technical Documentation and change notifications.
• Demonstrated expertise in compiling and maintaining EU MDR Technical Documentation.
• Experience interacting directly with regulatory authorities in the U.S., EU, and/or other global markets.
• Strong experience reviewing and advising on advertising and promotional materials for U.S. and EU markets.
• Demonstrated ability to develop and execute regulatory strategies that support business and product objectives.
• Collaborative, solution‑oriented professional with a strong focus on delivering value to stakeholders and the organization.

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):$120,000.00 - $180,000.00

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
• 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

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.

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.

We are that our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team.

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.

We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. 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

These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career‑building resources you need. Life‑transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight‑driven care. Fresh viewpoints. Cutting‑edge AI, data, and automation. You’re shaping the future of healthcare technology and defining the next generation of breakthroughs in care 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 setting is 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.

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