We anticipate the application window for this opening will close on - 11 Apr 2025 Position Description: Senior Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Responsible for developing regulatory strategies, preparing U.S, EU, and international submissions, and obtaining and maintaining approval for products and therapies to markets worldwide for Class I, II and III devices. Support Market Expansion and product development teams by preparing regulatory strategies and identifying regulatory requirements for submissions to ensure the efficient approval and registration of products worldwide. Assess the regulatory impact of changes to cleared & approved products and processes and coordinate the implementation of any resulting regulatory strategy. Prepare document packages for regulatory submissions from all areas of company and inspections for FDA Quality Systems Regulation (QSR). Compile all materials required in submissions, license renewal and annual registrations for submissions. Recommend changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance. Communicate with regulatory agencies and Notified Body and serve as regulatory liaison on the project team throughout the product lifecycle. Develop MDD and MDR design dossiers, technical files and change notifications and Design History Files for Class I, II and III devices. Work on Common Submission Dossier (CSDT), Device master file (DMF) and Japan shonin. Responsible for total product life-cycle regulatory activities to include pre-clinical, clinical, approval and post-approval. Navigate worldwide regulatory requirements and adhere to regulations including FDA medical device regulations like 21 CFR 800, 801, 803,814, Japan’s Pharmaceuticals and Medical Devices Act, EU Medical Device Directive 2007/47/EC, EU Medical Device Regulation (EU) 2017/745, Australia’s Therapeutic Goods Administration (TGA). Ensure product adherence to government and industry standards including Quality System Regulation (QSR 21 CFR 820), ASEAN Medical Device Directive (AMDD), CMDR, ISO 13485 and ISO 14971. *Multiple positions available. **This position is open to telecommuting from anywhere in the United States. #LI-DNI. Basic Qualifications: Master’s degree in Regulatory Affairs, Biomedical Engineering, Chemistry, or closely related field. Requires two (2) years’ experience as a Regulatory Affairs Specialist, R&D Engineer or related occupation in Regulatory Affairs / R&D Engineering. Experience must include two (2) years post-bachelor’s progressive experience with each of the following: MDD/MDR design dossiers, technical files and change notifications, and Design History Files for Class I, II and III medical devices; Common Submission Dossier (CSDT), Device master file (DMF) and Japan Shonin; Total product life-cycle regulatory activities to include pre-clinical, clinical, approval and post-approval; 21 CFR 800,801, 803,814, Japan’s Pharmaceuticals and Medical Devices Act, EU Medical Device Directive 2007/47/EC, EU Medical Device Regulation (EU) 2017/745, Australia’s Therapeutic Goods Administration (TGA) Regulations); QSR 21 CFR 820, ASEAN Medical Device Directive (AMDD), CMDR, ISO 13485, and ISO 14971. The position reports to Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432 and is open to telecommuting from anywhere in the United States. Salary: $114,400 to $133,200 per year THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at InternalJobs.Medtronic.com 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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page\_name=signon&co\_num=30601&co\_affid=medtronic) **Welcome to our new Careers Site!** **If you applied before July 22nd, please check your email for a notification from us providing you with instructions and a link to set up your new account and retain access to your current activity. If you do not see an email from us, please feel free to proceed with creating a new account.** 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 90,000+ 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. **We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. **We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. **This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will… + **Build** a better future, amplifying your impact on the causes that matter to you and the world + **Grow** a career reflective of your passion and abilities + **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: **Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. **Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. **Better outcomes for our world** . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care 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. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com