Regulatory Affairs Writer – Clinical Evaluations & Submissions in Keele

Regulatory Affairs Writer – Clinical Evaluations & Submissions in Keele

Keele Full-Time No working from home possible
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Biocomposites, based in Keele, UK, seeks a Regulatory Affairs Specialist (Technical Writing) to lead the creation and revision of clinical evaluation reports (CER) and assist with regulatory submissions such as FDA Q-submissions. The role requires coordinating with R&D, clinical, and regulatory teams, performing literature reviews, and ensuring compliance with EU MDR 2017/745 and MDCG guidance.

The position reports to the Senior Regulatory Affairs Specialist (Technical Writing) and is based at

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Contact Details:

Biocomposites Recruitment Team