Prin Regulatory Affairs Spec - Core Surgical innovations

We anticipate the application window for this opening will close on - 7 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 develops and executes strategies for global regulatory approvals to introduce new and modified medical device products to the market. The Principal Regulatory Affairs Specialist translates regulatory requirements into project/product requirements, prepares worldwide regulatory submissions and negotiates their approval. Responsibilities include participating on product development teams, developing global regulatory strategies, preparing US and international regulatory submissions, supporting pre and post market regulatory compliance activities and evaluating proposed product changes for regulatory impact and preparing necessary documentation.Responsibilities may include the following and other duties may be assigned.Develop and implement comprehensive global regulatory strategies for medical device submissions to ensure timely market access for New Product DevelopmentAuthor regulatory submissions, including but not limited to pre-submissions, premarket notifications (510(k)s), EU change notifications, and technical documentation.Serve as a key regulatory representative on cross-functional product development teams, providing strategic input, timelines, and direction.Review and approve product labeling, training materials, promotional content, and advertising for regulatory compliance.Support global pre-market and post-market regulatory activities to maintain product approval and lifecycle compliance.Oversee and coordinate multiple regulatory projects across domestic and international markets.Provide strategic leadership and mentorship to Regulatory Affairs Specialists in the development of regulatory submissions and interpretation of global regulations.Lead or coordinate the preparation of regulatory submission documentation, as well as internal audit and inspection readiness activities.Recommend and implement changes to labeling, manufacturing processes, marketing strategies, and clinical protocols to ensure regulatory compliance.Monitor and enhance regulatory tracking and control systems to drive process efficiency and documentation integrity.Maintain up-to-date knowledge of evolving global regulatory requirements, guidance, and industry best practices.Interface with regulatory authorities as required on defined matters, ensuring effective communication and resolution of issues.Actively participate in internal and external audits, providing subject matter expertise as needed.Review of promotional and advertising material.Must Have: Minimum RequirementsBachelors degree with 7+ years of regulatory affairs experienceORAn advanced degree with 5+ years of regulatory affairs experienceNice to Have7+ years of medical device regulatory affairs with roles showing increasing responsibilityExperience with FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standardsStrong leadership and team management skills. Excellent communication and interpersonal skills. Ability to thrive in a fast-paced, collaborative environment. Strong problem-solving and decision-making abilities. Experience with Notified Body audits. Collaboration and leadership skills in team setting including ability to coach and develop team members, and effective resource management to address multiple priorities. RAC credential preferredStrong interpersonal, analytical, writing, and organizational skills, including the ability to “navigate the grey”Ability to analyze and resolve non-routine regulatory issues using independent judgmentGood understanding of product development process and design control through knowledge of US FDA and international medical device regulationsDemonstrated history of successful regulatory submissions in the US and EUExperience with software-enabled medical devices, including artificial intelligence and machine learning technologies, as well as clinical trials and preclinical testing.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: Lafayette, Colorado, United States of America; Mansfield, Massachusetts, United States of America; Mounds View, Minnesota, United States of America; North Haven, Connecticut, United States of America; Boston, Massachusetts, United States of AmericaType: Full time