Associate Regulatory Affairs Specialist

Associate Regulatory Affairs SpecialistAt Medtronic, you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Join the Medtronic Cardiac Ablation Solutions (CAS) regulatory affairs team of innovators who bring their worldview, unique backgrounds, and individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, and we believe that this drives healthcare forward and sets us apart as a global leader in medical technology and solutions. Cardiac Ablation Solutions is focused on disrupting the Electrophysiology (EP) market to be the number one arrhythmia care, cardiac mapping, and ablation solutions provider for our customers and patients. Inspired by the Medtronic mission and dedicated to transforming the lives of people with cardiac arrhythmias, to date CAS has transformed the lives of over 1 million patients. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This position will be based in Mounds View, MN.Roles and Responsibilities+ Understanding global regulatory requirements and how to research detailed requirements. + Contributing to global product registration maintenance, including EU MDR Technical Documentation/MDD Technical Files. + Assessing device changes for registration implications and electronically notifying geographies of regulatory changes. + Routing regulatory documents for approvals in electronic systems, maintaining approval information, and maintaining electronic document collections. + Supporting requests to systems relating to product release, economic operator verification, and registration and listing. + Participating in preparation for internal and external regulatory audits. + Compiling materials required for new global product submissions, license renewals, and change submissions. Monitoring, maintaining, and improving global regulatory tracking/control systems. + Requesting, obtaining, and maintaining FDA Certificate of Foreign Government (CFGs) including notarization and legalization, EC/ISO certificates and various other regulatory documents. + Keeping abreast of regulatory procedures and changes. + Performing other regulatory duties as needed.Must Have (Minimum Requirements)To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. + Bachelor's degree + 0 years of regulatory affairs or related experienceNice to Have (Preferred Qualifications)+ Bachelor's Degree in a health profession, science and/or engineering field + Experience in medical device industry + Demonstrated technical writing skills + Strong computer skills, including word processing, spreadsheets and slide presentations + Excellent organizational, project management skills + Strong written, verbal and interpersonal skills + Notary licensePhysical 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.Benefits & CompensationMedtronic 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):$60,000.00 - $90,000.00 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 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.About MedtronicWe 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 95,000+ 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 LivesEach 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 TeamWith 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 EngineerBy 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 learningThese 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.