Regulatory Affairs Specialist - Minneapolis

At 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.A Day in the LifeMedtronic pioneered the field of neuromodulation with the first commercially available spinal cord stimulator to treat chronic pain and engineered the first deep brain stimulation (DBS) system to treat movement disorders and the first implantable drug pump to deliver medication directly to the intrathecal space of the spine. More than 40 years later, we continue to innovate, constantly challenging ourselves to disrupt the markets we created. We advance science by thinking and acting boldly, bringing together the right people with the right breadth of expertise to engineer groundbreaking therapies and technologies.The Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to introduce products and changes to the market, provides advice on regulatory requirements, prepares submissions, and negotiates their approval. The RA Specialist also assists with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and Manufacturing site registrations.Responsibilities may include the following and other duties may be assigned.Prepare FDA, European, and Canada submissions for product changes as required to ensure timely approval for market release. Review significant regulatory issues with the supervisor, as necessary, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed.Prepare regulatory strategies/plans and compliance requirements. Provide ongoing support to project teams for regulatory issues and questions. Find, interpret, and apply regulations and guidance appropriately for situations.Provide business and product information to enable the development of strategies and requirements and communicate that information to the Project teams.Provide regulatory support for currently marketed products. This includes reviewing labeling and changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required.Complete understanding and wide application of technical or regulatory principles, theories, and concepts. General knowledge of other related disciplines.Participate in the project team meeting to plan strategies, including reviewing the various specifications and plans/reports, defining target market and distribution method, Medtronic requirements on testing, etc.Provide regulatory product portfolio analysis and review with other functional resources, such as Marketing, Global Supply Chain, etc. Maintain Regulatory Affairs product files to support compliance with regulatory requirements.Work under general supervision following established procedures. Independently determines and develops an approach.Frequent inter-organizational contact and some external contacts. Keeps current on global directives, harmonized standards and procedures, and communicates changes that may affect cross-functional areas.Other tasks, as requiredMust Have: Minimum RequirementsBachelor's degree requiredMinimum of 2 years of regulated industry experience.Nice to HaveExperience working in a regulated biotechnology environment, including regulatory submissions, interactions with regulatory agencies (e.g., FDA and BSI), and cross-functional project teams. In-depth experience with FDA requirements, guidance documents, Active Implantable Medical Device Directive/ EU Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards Experience with Class III medical devices (PMA) and active implantable devicesStrong negotiation skills and written/oral communication skillsStrong organizational skills and time management skillsComputer skills: MS Office, MS Project, Adobe Acrobat, and AgilePhysical 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.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):$69,600.00 - $104,400.00This 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 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 to others).About MedtronicMedtronic benefits and compensation plansWe 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.Learn more about our business, mission, and our commitment to diversity here.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.At Medtronic, most positions are posted on our career site for 3-7 days.