We anticipate the application window for this opening will close on - 31 Mar 2026

 

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.

A Day in the Life

The Senior Principal Regulatory Affairs Specialist will play a key role in creating regulatory strategies and submissions to bring new robotic products to the global markets. This role will also work on new product development, as well as work on sustaining/post-market regulatory activities for Class II robotic devices. Devices that are part of the Robotics Surgical Technology Business are inclusive of hardware and software components.  The senior principal specialist will work directly with new product development and sustaining teams to develop the global regulatory strategy and support regulatory activities throughout the product lifecycle.  The senior principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide for Class II medical devices. This includes support of product changes to ensure that regulatory requirements continue to be met, documenting regulatory decisions, submissions to agencies, reviewing promotional materials, and ensuring that product technical documentation is current and accurate. Responsibilities are performed through the collaboration with various functions across the business unit, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality, and Marketing.

Responsibilities also include keeping senior management informed of the regulatory status of products and significant regulatory issues and maintaining proficiency in global regulatory requirements.  

The successful candidate will be able to deal with advanced concepts and undefined paths, work independently, develop new and creative regulatory strategies and work collaboratively within the Regulatory department and other business functions.

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

• Develop and support global regulatory strategies for Class II devices and accessories for robotic surgical application.
• Be an active member of the product development core teams and responsible for identifying submission deliverables, timelines, and strategic direction.  Reviews and approves technical documentation.
• Provide feedback and work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies and provide ongoing support to product development teams to assure timely resolution to regulatory issues and questions.
• Prepare FDA IDE submissions, DeNovo/510(k) submissions, or EU submissions for new products and product changes as required.
• Directly communicates with regulatory authorities to resolve questions/issues that arise prior to and during product submissions or other pertinent issues.
• Participate in the product change assessments and define the regulatory impact of product changes in global markets.
• Provide support to market released products as necessary. This includes reviewing labeling, product changes, and documentation for changes requiring regulatory approval.
• Keeps abreast of new and changing global regulatory requirements and keep the business informed of implications of changes
• Collaborate with International regulatory teams to understand worldwide regulatory requirements to enable the development of strategies and requirements for global commercialization. Interact directly with major market regulatory agencies in support of product registration, approval, and commercialization.
• Leads or performs coordination and preparation of document packages for global regulatory submissions, license renewals, internal & external audits and inspections.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Plays an active role in continuous improvement of regulatory processes for the Robotics Business Unit.

Must Have: Minimum Requirements

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

Nice to Have

• Degree in Engineering
• Experience with US and EU submissions (e.g. 510(k), PMA, Pre-Sub, PCCP, IDE, MDR, etc.) with complex medical device systems including hardware, software and artificial intelligence
• Demonstrated ability for strategic thinking, project planning
• Strong influence skills. Demonstrated ability to work cooperatively at all levels in an organization to build and maintain relationships required to accomplish program goals
• Ability to balance priorities, work independently or collaboratively to determine and develop solutions
• Excellent verbal/ written communication and presentation skills. Demonstrated ability to succinctly and accurately communicate to various cross functional partners.

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.

Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.

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):$156,800.00 - $235,200.00

 

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 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

About Medtronic

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.

Learn more about our business, mission, and our commitment to diversity here.

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.