Sr Regulatory Affairs Specialist

We anticipate the application window for this opening will close on - 11 Aug 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 Senior Regulatory Affairs Specialist will play a key role in supporting regulatory strategies and submissions for Robotics Surgery technologies in global markets. This role will contribute to new product development, as well as sustaining and lifecycle management activities for Class II medical devices that include hardware and software components. The Senior Regulatory Affairs Specialist will work closely with new product development and cross functional sustaining teams to help define global regulatory strategy and support regulatory activities throughout the product lifecycle, from concept and development through commercialization, post-market support, and product changes. This individual has primary responsibility for supporting compliance with U.S. and EU regulatory requirements and will partner with international regulatory affairs colleagues to support worldwide submissions for Class II medical devices. Responsibilities include supporting design changes, labeling updates, product modifications, and other lifecycle management activities to ensure ongoing regulatory compliance. Additional responsibilities include documenting regulatory decisions, preparing and supporting agency submissions, assessing regulatory impact of product and process changes, reviewing promotional materials, and ensuring product technical documentation remains current, accurate, and aligned with applicable regulatory requirements. This work is performed through collaboration with cross-functional partners across the business unit, including Regulatory Affairs, Research and Development, Clinical, Quality, Manufacturing, and Marketing. Additional responsibilities include keeping senior management informed of product regulatory status and significant regulatory issues, while maintaining strong knowledge of global regulatory requirements. The successful candidate will be comfortable working with advanced concepts and ambiguity, able to operate independently, develop creative regulatory strategies, and collaborate effectively within Regulatory Affairs and across other business functions.Responsibilities may include the following and other duties may be assigned. Provides regulatory strategy, submission support, and compliance oversight for surgical robotics medical devices across the product lifecycle. Recommends changes for labeling, manufacturing, software, cybersecurity, marketing, and design of medical devices for regulatory compliance. Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Leads or compiles all materials required in submissions, license renewal and annual registrations. Monitors and improves tracking / control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters.Must Have: Minimum Requirements Bachelor’s degree required Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience. Nice to Have Advanced degree in regulatory affairs, biomedical engineering, life sciences, or related field RAC certification or progress toward RAC certification Experience supporting Class II and Class III medical devices Working knowledge of global regulatory requirements, including FDA, EU MDR, Health Canada, and other international markets Experience preparing or supporting 510(k), PMA, Technical Documentation, or international submissions Familiarity with design controls, risk management, and usability engineering Understanding of software-enabled devices, cybersecurity, or AI-enabled products, if relevant to the portfolio Experience working with cross-functional teams including R&D, quality, clinical, marketing, and manufacturing Knowledge of applicable standards such as ISO 13485, ISO 14971, IEC 60601, and IEC 62304 Experience with regulatory impact assessments for design changes, labeling updates, and product lifecycle management Strong technical writing, document review, and submission authoring skills Experience interacting with regulatory authorities, notified bodies, or internal auditors Project management skills with ability to manage multiple priorities and deadlines Strong communication and influence skills in a matrixed organization Experience with surgical, capital, or robotic medical devices.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):$92,000.00 - $138,000.00This 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; Boston, Massachusetts, United States of America; New Haven, Connecticut, United States of AmericaType: Full time