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
* Work collaboratively within a cross-functional team environment, ensuring compliance with quality and safety standards
Requirements:
* 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