Medtronic—Clinical Evaluation Medical Writer

Job description

Description: Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend 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+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life As a Clinical Evaluation Medical Writer you will be a key member of the Medtronic medical writing team responsible for maintaining highest standards of product reliability and patient well-being through gathering and analysis of data, write reports, and communicate with regulatory agencies as needed on ensuring product safety. The primary responsibilities are creating and maintaining Clinical Evaluation Plans & Reports (CEP / CER), and Summary of Safety and Clinical Performance report (SSCP) and may include associate documentations like Periodic Safety Update Reports (PSUR) etc. that support the presentation, publication, regulatory clinical document submission needs of assigned therapeutic areas including class III and implantable medical devices, Class IIb, Class IIa medical devices. Responsibilities may include the following and other duties may be assigned: - Prepare, edit, and review clinical and regulatory documents, including Clinical Evaluation Reports, clinical study reports or summaries, Summary of Safety and Clinical Performance reports, Periodic Safety Update Reports, and responses to Notified Body questions. - Develop clear, accurate, and timely responses to audit and submission-related queries. - Maintain databases of relevant peer-reviewed literature and clinical evidence. - Critically appraise, analyze, summarize, and discuss clinical evidence from all available sources. - Conduct comprehensive literature searches and perform critical evaluations of clinical evidence. - Develop state-of-the-art assessments for assigned product families in alignment with their intended purpose. - Prepare and edit manuscripts, abstracts, clinical study documents, scientific reports, special data summaries, monographs, comprehensive reviews, scientific exhibits, and other medical communication materials for regulatory submissions or internal use, as required. - Collaborate regularly with cross-functional teams to gather and analyze data related to the safety and performance of medical devices and provide solution-oriented recommendations. - Monitor evolving safety regulations, guidance documents, and industry expectations to support ongoing compliance. - Apply knowledge of ISO 13485, ISO 14971, EU MDR, and applicable product-specific industry standards. - Independently identify, assess, and analyze relevant clinical data from scientific publications and other credible sources. Required knowledge and experience: - B.Pharma + M.Pharma , M.Sc. / Master’s degree in Pure or Applied Sciences, including Biochemistry, Biotechnology, Microbiology, Nursing, and other relevant Life Sciences disciplines, MBBS degree or a Doctorate in Pure or Applied Sciences. - 4-8 years experiences as a medical/clinical writer in medical device and or pharmaceutical industry. A mix is preferred in case of pharma - Knowledge of US / EU Quality Systems regulations, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards - Strong written, organizational, and communication skills, with a flexible and team-oriented approach. - Strong attention to detail, effective planning skills, and the ability to manage multiple priorities under time-sensitive conditions. - Proficiency in English, including reading, writing, and verbal communication. - Demonstrated learning agility and commitment to continuous professional development. Nice to Have: - Experience working effectively with global and cross-functional teams. - Relevant medical writing industry certifications. 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.  ‌ ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com. 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).