Richmond
Associate Medical Writer – Remote, UK – Medical Device About 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, • 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