Medical Writer Apply
Associate Medical Writer – Remote, UK – Medical DeviceAbout the Company:We are looking for a Medical Writer with experience in CER writing (clinical evaluation report) to join a group of expanding medical device companies.Responsibilities:Develop and contribute to key clinical and regulatory documents, including Clinical Evaluation Plans/Reports (CEP/CER), Post-Market Clinical Follow-Up (PMCF) Plans/Reports, Post-Market Surveillance (PMS) documentation, and Summaries of Safety and Clinical Performance (SSCP) Conduct scientific literature reviews and produce reports (e.g. periodic safety updates, annual literature reviews) to support global regulatory submissions Apply robust scientific methodologies to generate high-quality clinical evidence and documentation Create and maintain SOPs, work instructions, and templates to ensure compliant clinical documentation processes Collaborate cross-functionally to support product lifecycle activities, including risk management, vigilance, labelling, and promotional materials Support regulatory submissions by addressing queries from notified bodies, auditors, and regulatory authorities Contribute to issue resolution, CAPA activities, and continuous improvement initiatives Work collaboratively within a cross-functional team environment, ensuring compliance with quality and safety standardsRequirements:Bachelor’s degree in science.Excellent English communication skills.Experience with writing clinical evaluation reports for medical devices.Willingness to travel when needed.PLEASE NOTE THAT CANDIDATES ARE REQUIRED TO BE BASED IN THE UK AND HAVE THE RIGHT TO WORK IN THE UK

