Prin Regulatory Affairs Spec

We anticipate the application window for this opening will close on - 2 Sep 2026Careers 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 LifeThe 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 portfolioProvide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulationsPrepare Pre-Sub and 510(k) submissions and technical documents to support CE mark and other international submissionsParticipate in negotiations and interactions with regulatory authorities during the development and review processProvide business and product information to the international regulatory affairs team to enable development and strategies and requirements and communicate that information to the business teamSupport international product registrations as neededManage multiple projects and prioritize tasks on day by day basis to meet project schedulesCollaborated with engineering, quality, clinical, marketing, and other functions to fulfill responsibilitiesReview promotional and advertising materialMaintain current regulatory knowledge of domestic and international regulations, guidelines, and standardsCreate or revise departmental procedures to improve operations or to reflect changing regulatory requirementsParticipate in internal and external auditsMaintain regulatory affairs documentation to support compliance with applicable regulatory requirementsPerform other duties as assigned or required.Must Have: Minimum Requirements Bachelor’s degree requiredMinimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.Nice to HaveExperience successfully achieving FDA clearance through a 510(k) submissionExperience interacting directly with the FDAExperience managing or contributing to multiple regulatory submissionsFamiliarity with medical 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 RequirementsThe 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. ‌Recruitment Fraud AlertWe are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at View email address on click.appcast.io. ‌Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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 - $180,000.00This 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 plansIt 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 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.SummaryLocation: North Haven, Connecticut, United States of America; Mansfield, Massachusetts, United States of America; Mounds View, Minnesota, United States of America; Boston, Massachusetts, United States of America; Lafayette, Colorado, United States of AmericaType: Full time