We anticipate the application window for this opening will close on - 3 Jun 2026

At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

The Principal Regulatory Affairs Specialist will play a key role in launching new products and sustaining the Wound Management product portfolio. As a new product development (NPD) core team member the principal specialist works directly with the NPD team from the opportunity phase through commercialization. The 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 Wound Management devices. Sustaining regulatory responsibilities include reviewing product labeling changes to ensure that regulatory requirements continue to be met documenting no file decisions reviewing promotional materials and ensuring that our product technical documentation is current and accurate. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices.

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

• Provide regulatory affairs domain expertise and influence at all levels in support of the Wound Management device portfolio

• Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications considering both domestic and international regulations

• Prepare Pre-Sub and 510(k) submissions and technical documents to support CE mark and other international submissions

• Participate in negotiations and interactions with regulatory authorities during the development and review process

• Provide business and product information to the international regulatory affairs team to enable development and strategies and requirements and communicate that information to the business team

• Support international product registrations as needed

• Manage multiple projects and prioritize tasks on day by day basis to meet project schedules

• Collaborated with engineering quality clinical marketing and other functions to fulfill responsibilities

• Review promotional and advertising material

• Maintain current regulatory knowledge of domestic and international regulations guidelines and standards

• Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements

• Participate in internal and external audits

• Maintain regulatory affairs documentation to support compliance with applicable regulatory requirements

• Perform other duties as assigned or required.

Must Have: Minimum Requirements

• Bachelors degree required

• Minimum of 7 years of relevant experience or advanced degree with a minimum of 5 years of relevant experience.

Nice to Have

• Experiencesuccessfully achieving FDA clearance through a 510(k) submission
• Experience interacting directly with theFDA
• Experience managing or contributing tomultiple regulatory submissions
• Familiarity withmedical device regulatory lifecycle management.

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 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 lifewhere 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):$120000.00 - $180000.00

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 insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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 95000 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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.