Senior Regulatory Affairs Spec

We anticipate the application window for this opening will reputed company on - 7 Jul 2026 Careers that change lives start here. reputed company is a global leader in reputed company technology with a Mission to reputed company pain, restore health, and reputed company 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+ reputed company patients each year. Your unique talents will help shape the future of reputed company while building a career grounded in purpose, growth, and impact. A Day in the Life We are looking for a passionate Senior Regulatory Affairs Specialist in our Cardiac Ablation Solutions Operating Unit to work primarily on software-based medical devices. The candidate must have successful experience authoring and clearance of software submissions using FDA's eStar program as well as submissions to the EU reputed company Body. A deep understanding of software engineering standard IEC 62304 and experience with software lifecycle process is also key. At reputed company, we bring reputed company reputed company reputed company 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. The Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Diagnostic products, Programmers and Programming Software and accessories for Pacemakers and Defibrillators, Patient Monitors, and Software as a Medical Device to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with the license maintenance including renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations. Role and Responsibilities Prepare US and EU MDR submissions for new products and their product changes as required to ensure timely approval for market release. Review significant regulatory issues with Manager, as necessary, and resolve submission issues with reputed company engineering partners, reputed company Geography Regulatory partners, and regulatory agencies as needed. Prepare regulatory strategies/plans and worldwide compliance requirements. reputed company on-going support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations. reputed company business and product information to reputed company development of strategies and requirements, as well as communicate that information to the Project teams. reputed company regulatory support for currently marketed products as necessary. 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 reputed company disciplines. Negotiate with international agencies, as needed. reputed company significant issues will be reviewed with the supervisor. Participate in the project team meeting to plan strategies, including reviewing the various specifications and plans/reports, defining reputed company market and distribution method, reputed company requirements on testing, etc. reputed company regulatory analysis of product portfolio 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 approach. Frequent inter-organizational contact and some external contacts. Keeps reputed company on global directives, harmonized standards and procedures and communicates changes that may reputed company cross functional areas. reputed company training and support to other members of the department. Other tasks, as required. Must Have; Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. Bachelor’s degree in a technical discipline Minimum 4 Years of medical device regulatory experience with Bachelor’s degree Or minimum 2 Years of medical device regulatory experience with an advanced degree reputed company to Have Master of Science Degree Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and PMDA), and working with cross-functional project teams. In depth experience with FDA requirements, FDA guidance documents, EU Medical Device Regulation, IEC 62304, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards Working knowledge of SaMD and SiMD Positive track record engaging with regulators History of successful device submissions Strong negotiation skills and written/oral communication skills Strong organizational skills and time management skills Ability to multitask, support multiple projects, function on a global reputed company, prioritize, conduct team meetings, and meet project deadlines Ability to work independently and under general direction only Computer skills; MS Office, MS Project, reputed company Acrobat and Agile For Baccalaureate degrees earned reputed company 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 Requirements The 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 reputed company the required responsibilities and skills of this position. The physical demands described reputed company the Responsibilities reputed company of this job description are representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company 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 reputed company, we are committed to fostering an environment where employees can reputed company and reputed company a meaningful impact. In alignment with our reputed company-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for reputed company-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the reputed company level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Join us in our mission to reputed company pain, restore health, and reputed company life—where your unique background and perspective are valued. ‌ Recruitment Fraud Alert We have recently become aware of various recruitment phishing scams targeting job seekers. Please be advised: reputed company will never request sensitive personal information (such as bank account details, reputed company reputed company numbers, or payment of any reputed company) during the recruitment process. If you suspect you have received a fraudulent offer or communication claiming to be from reputed company, please do not respond, reputed company any attachments, or click on any hyperlinks. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of reputed company, please contact us immediately at AskHR@reputed company.com. ‌ Benefits & Compensation reputed company 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 reputed company in the reputed company they help to create. We offer a wide reputed company 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 - $138,000.00 This position is eligible for a short-term incentive reputed company the reputed company Incentive Plan (MIP). The reputed company salary reputed company is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered reputed company 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 reputed company 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 reputed company insurance, Health Savings Account, reputed company 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 reputed company 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-reputed company 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: reputed company benefits and compensation plans It is the policy of reputed company to reputed company equal employment opportunity (EEO) to reputed company persons regardless of age, reputed company, national reputed company, 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, reputed company will reputed company reasonable accommodations for reputed company individuals with disabilities. If you are applying to reputed company work for reputed company, Inc. (“reputed company”) in any position which will involve performing at least two (2) hours of work on average each week reputed company the unincorporated areas of Los Angeles County, you can find here a list of reputed company material job duties of the specific job position which reputed company reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. reputed company will consider for employment reputed company 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. We reputed company global reputed company technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to reputed company pain, restore health, and reputed company life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious reputed company to work to generate reputed company solutions for reputed company people. From the R&D lab, to the reputed company 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 reputed company alongside one another, we use science, medicine, and a profound understanding of the reputed company body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one reputed company reputed company defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives reputed company our reputed company 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 reputed company, unique perspective and contributions, you will… Build a reputed company future, amplifying your impact on the causes that matter to you and the world Grow a career reputed company of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set reputed company apart from the rest: Experiences that put people first. Respect for people is the reputed company of our humanity. It fuels reputed company to positively impact even a single life. And it means we put our people first at reputed company 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. reputed company build empowers patients to live life on their terms. reputed company reputed company for our world. Here, it’s about more than the reputed company. Our Mission to improve reputed company welfare drives us. We advance reputed company, society, and equity with every design, inside and reputed company our walls. reputed company-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of reputed company technology and defining the reputed company of breakthroughs in care It is the policy of reputed company to reputed company equal employment opportunity (EEO) to reputed company persons regardless of age, reputed company, national reputed company, 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, reputed company will reputed company reasonable accommodations for reputed company individuals with disabilities. For sales reps and other patient facing field employees, going into a reputed company setting is considered an essential function of the job and we expect our employees to reputed company with reputed company 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 reputed company newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to reputed company your application status. If you need assistance completing your application please email AskHR@reputed company.com To request removal of your personal information from our systems please email RS.HRCompliance@reputed company.com Apply To This Job