Principal Clinical Evaluation Medical Writer

We anticipate the application window for this opening will close on - 22 Apr 2026 **Position Description:** Principal Clinical Evaluation Medical Writer for Medtronic, Inc located in Mounds View, MN. Responsible for authoring clinical and scientific documentation to support product and therapy approval and use worldwide. Responsible for authoring clinical study documentation, including Clinical study reports, Investigator's brochure, Clinical study protocols, Informed consent forms, Case report forms, Common technical document (CTD) modules and Biowaiver applications. Author scientific abstracts, posters, manuscripts and consensus guidelines for publication in scientific journals and podium presentations for Key Opinion Leaders (KOL). Review and analyze clinical evidence from clinical studies and scientific literature. Create responses for regulatory deficiency letters, audit and submission queries. Develop and maintain clinical documentation for cardiac surgery device regulatory submissions, including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post Market Clinical Follow-up Plan/Report (PMCFP/R), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Update Reports (PSURs). Responsible for EU Medical Device Regulation (EU MDR) submissions for devices related to surgical cardiac ablation and extracorporeal circulation. Navigate the complexities of various government and industry regulations for the EU MDR, including EU MDR 2017/745, EU MEDDEV Guidance 2.7/1 Rev. 4, Medical Device Coordination Group (MDCG) MDCG-2019-9, MDCG-2020-5, MDCG-2020-6, MDCG-2020-7 and MDCG-2020-8. Position works a hybrid model and will be onsite at Mounds View, MN 4 days per week. Relocation assistance not available for this position. #LI-DNI. **Basic Qualifications:** Masters' Degree in Biomedical Sciences, Medicine, Pharmacology, or related technical disciplines with five (5) years of experience as a medical writer or related occupation. Must possess at least five (5) years' experience with each of the following: Authoring clinical study documentation; Authoring scientific abstracts, posters, manuscripts and consensus guidelines for publication in scientific journals and podium presentations for KOL; Reviewing and analyzing clinical evidence from clinical studies and scientific literature; and Creating responses for regulatory deficiency letters, audit and submission queries. Must possess at least one (1) year of experience in each of the following: EU MDR submissions for devices related to surgical cardiac ablation and extracorporeal circulation; Creating clinical documentation for regulatory submissions, including CEPs, CERs, PMCFP/R, SSCP, and PSURs; EU MDR 2017/745, MEDDEV 2.7/1 Rev. 4, Medical Device Coordination Group (MDCG) MDCG-2019-9, MDCG-2020-5, MDCG-2020-6, MDCG-2020-7 and MDCG-2020-8. Position works a hybrid model and will be onsite at Mounds View, MN 4 days per week. Relocation assistance not available for this position. #LI-DNI. **Salary:** $147,000 to $196,800 per year 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 (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 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 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 (. 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@ To request removal of your personal information from our systems please email RS.HRCompliance@

Created: 2026-04-15