Senior Clinical Evaluation Medical Writer

Job Description 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 Life The Clinical Evaluation Medical Writer on our Endoscopy team plays a key role in developing and updating clinical evaluation documents (e.g., CEP, CER, PMCFP, PMCFR, SSCP) to support CE Mark submissions and maintain compliance throughout the product lifecycle. This work follows MEDDEV 2.7/1 Rev. 4 and EU Regulation 2017/745 and involves close collaboration with cross-functional teams to gather and interpret data on device safety, performance, and benefit-risk. In addition, the writer supports related activities such as summarizing and disseminating clinical literature and other available data to share relevant evidence, while also managing Medical Information activities. This includes tracking inquiries, monitoring key metrics, researching and responding to technical and clinical questions from both internal teams and external healthcare professionals, all under the appropriate guidance of Clinical and Medical Affairs. Success in this role requires strong skills in scientific writing, literature review, data analysis, and clear communication, along with a proactive and collaborative mindset. Responsibilities may include the following and other duties may be assigned. - Independently creates and maintains clinical evaluation documents (CEP, CER, PMCFP, PMCFR, SSCP) in compliance with MEDDEV 2.7/1 Rev 4, MDD, EU MDR 2017/745, MDCG guidance, and company procedures. - Supports Medical Information activities by leveraging scientific expertise to research and respond to inquiries from healthcare professionals and internal teams, maintaining related documents and reports. - Performs thorough literature searches and reviews clinical evidence from studies, reports, and available post-market data. Summarizes and combines this information to support product submissions, clinical evaluations, and Medical Information inquiries. - Reviews scientific materials like abstracts, posters, manuscripts, slides, and promotional content to check for accuracy, proper claims, off-label use, and compliance with company policies. - Develops state-of-the-art reports for product families and reviews cross-functional documents such as IFUs and Risk Management files to ensure alignment on safety and risk information. - Identifies and reports complaints or adverse events from literature to the Global Complaint Handling team. - Creates responses to audit and submission queries and maintains a database of peer-reviewed literature. - Collaborates with key stakeholders to drive evidence-based scientific decisions and maintain compliance with regulatory and corporate guidelines. - Communicates project timelines, input requirements, and risks clearly and promptly with cross-functional teams. Required Knowledge and Experience: - Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. - May have broad knowledge of project management. - Requires a Baccalaureate degree and total 8 years of experience with minimum 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience. 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 all the required responsibilities and skills of this position. Benefits & Compensation Medtronic 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. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). About Medtronic 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. Learn more about our business, mission, and our commitment to diversity here