Why join Stryker We are proud to be named one the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting Our total rewards package offering includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific. Know someone at Stryker Be sure to have them submit you as a referrral prior to applying for this position. Learn more about our Who we want Hard-working winners. Confident, competitive and results-oriented professionals who create a track record of success. Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders. Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices. What you will do Conduct literature searches for drugs, medical devices, and cosmetics. Interpret and synthesize the information in clinical regulatory documents, in compliance with global requirements, including pharmacovigilance. Work in a cross-functional team and write clinical study protocols and reports, data summaries from raw data, and develop document strategies. Compile clinical evidence from multiple sources such as current and past clinical trials, post market clinical follow up data and literature review updates, ad-hoc analysis, meta-analyses, or other sources of safety and performance data (e.g. investigator-initiated study clinical data) and synthesize the information in support of European Medical Device Regulation (EU MDR). Develop and complete Clinical Evaluation Reports (CERs) for new and legacy medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing CERs. Collaborate cross-functionally to provide input for design teams clinical EU MDR requirements. Translate complex scientific and technical information into accessible content for various audiences, including regulatory bodies. For all documents, coordinate and manage the review process, and lead discussions on document revision. Challenge conclusions when necessary. Independently resolve document content issues and questions from external and internal reviewers and ensure timely approvals from all reviewers. Assist in the development of internal procedures, templates, and style guides. Serve as a subject matter expert within the department. Assist in the maintenance of the library for all relevant literature. What you need: A master's degree required preferably in a Scientific Discipline. 10+ years of Industry experience in pharma or medical devices is required 6+ years of experience in Scientific or Medical Writing, relevant academic or clinical research experience (Masters or PhD) is preferred. Orthopedic experience preferred, including experience with implants or spine instruments. A master's degree required preferably in a Scientific Discipline. 10+ years of Industry experience in pharma or medical devices is required 6+ years of experience in Scientific or Medical Writing, relevant academic or clinical research experience (Masters or PhD) is preferred. Orthopedic experience preferred, including experience with implants or spine instruments. Understanding and experience in the use of scientific journals, publication guidelines, databases, search strategies, literature management software required Excellent scientific and medical writing skills required. Must be able to think analytically, can interpret data from scientific literature and clinical studies and synthesize the results and in a clear, concise, and scientifically accurate manner in the clinical document. Ability to apply ISO, FDA and related guidelines toward writing strategy and documentation required. Must be able to work and make independent decisions and be able to take the initiative to lead projects and assignments. Demonstrated ability to work effectively with cross-functional internal (Regulatory, Marketing, Research & Development) and external stakeholders (Physicians, CROs, Medical Staff, etc.) across multiple businesses. Expert knowledge and experience with MEDDEV 2.7/1 Rev. 4, EU Medical Device Regulation 2017/745 (MDR) and MDCG compliant clinical evaluations and clinical study documents preferred Knowledge in clinical operations, risk management, regulatory submissions and US and international guidelines preferred. Technical aptitude and attentiveness to detail. Excellent working knowledge of regulatory guidelines (FDA/CFR EN540/ Med DEV/GCP/EU MDR/MDCG) and quality standards (ISO 14155/14971) and medical/scientific/disease state terminology. About Stryker Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at
