Medical Writer
hace 4 días
York
Medical Writer (Medical Devices) North Yorkshire with hybrid working Everything you need to know about the role: This is an opportunity to join a growing medical device organisation as a Medical Writer, supporting the full clinical lifecycle of medical devices. The role plays a key part in clinical documentation, post-market surveillance (PMS), and post-market clinical follow-up (PMCF), working closely with regulatory, quality, and cross-functional stakeholders to ensure ongoing compliance and successful product support. You’ll be involved in both pre- and post-market activities, contributing to technical documentation, audits, and new product development projects within a collaborative and quality-driven environment. You will: • Prepare and maintain clinical documentation, including Clinical Evaluation Plans and Reports, • Develop post-market documentation such as PMS plans, PMS reports, PSURs, and PMCF plans and evaluation reports, • Evaluate and analyse clinical evidence from literature, clinical investigations, PMS and PMCF activities, • Maintain and analyse post-market surveillance survey data, • Ensure compliance with applicable regulations, guidance, and internal SOPs, • Provide clinical input into risk management files, labelling, IFUs, marketing materials, and patient information, • Support claim substantiation and maintenance of device claims, • Support internal and external audits, including QMS audits, • Experience within the medical devices sector, • Strong clinical or medical writing experience, • Working knowledge of MDR, MDD, UK MDR, IVDR/IVDD and relevant ISO standards, • Experience preparing and maintaining clinical evaluations and post-market documentation, • Ability to interpret clinical data, literature, and regulatory requirements, • Experience with market submissions and regulatory approval, • Exposure to internal and external audits, • Experience compiling technical dossiers and working to MEDDEV/MDCG guidance, • A varied and hands-on role within a growing medical device business, • Exposure to the full product lifecycle, from development through post-market, • Opportunities to work cross-functionally and develop regulatory and clinical expertise If you enjoy clinical writing, thrive in regulated environments, and want to build or deepen your career in medical devices, this role offers the chance to make a real impact across multiple products and projects.