Regulatory & Clinical Writer (Part-Time)
Duration: 12-Month Contract
Working Pattern: 2–3 days per week
Location: Hertfordshire, UK (Hybrid/Remote)
A small and growing medical device organisation specialising in wound care. Seeking an experienced Regulatory & Clinical Writer on a part-time contract basis. This is a pivotal role where you will act as the organisation’s go-to expert across Clinical/Regulatory writing. Taking full ownership of the function while shaping strategy and implementing scalable processes.
This opportunity is ideal for a contractor who enjoys working in agile environments, where autonomy, visibility, and real influence are part of the day-to-day.
- Lead clinical sections of Technical Files (EU MDR Annex II & XIV)
- Author and maintain Clinical Evaluation Reports (CERs)
- Conduct literature reviews, clinical appraisal, and gap analysis
- Define clinical evidence and PMCF strategy
- Ensure alignment between clinical data, risk, and product claims
- Support Notified Body interactions and audit readiness
Requirements:
- Strong experience in Clinical Affairs or RA/Clinical roles
- Proven CER authorship under EU MDR
- Deep understanding of clinical evidence in Technical Documentation
- Experience in SME or fast-paced environments
- Excellent writing and stakeholder skills
What’s on Offer:
- Flexible part-time contract (2–3 days per week) over a 12-month period
- High level of autonomy and strategic influence
- A chance to make tangible impact within a growing, close-knit organisation
The ideal person will be based around the London/Hertfordshire area and be able to travel to the site to collaborate with the team.
For more information, please contact
