Regulatory Affairs Writer – Clinical Evaluations & Submissions

Biocomposites; Keele; On-site; GBP 45,000 - 65,000; Full time

Benefits offered by this job

Company events

Company pension

Employee discount

Free or subsidised travel

Free parking On-site

Job summary

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

Qualifications

• Bachelor’s Degree in life science or equivalent.
• Minimum 5+ years of Technical Writing experience in pharma/medical device.
• Experience writing CERs and PSURs per EU MDR 2017/745 and MDCG guidance.
• Experience with systematic literature searches and reviews.
• Experience with regulatory submissions including EU MDR and US FDA Q-submissions.
• Compilation of Technical Files/Documentation to MDR 2017/745 or MDD 93/42/EEC.
• Knowledge of ISO13485/ISO14971/ISO10993 and MDSAP.
• Proficient in MS Office (Word, Excel); familiarity with Endnote/Reference Manager.

Responsibilities

• Prepare and revise clinical evaluation reports and other regulatory documents.
• Collaborate with R&D, clinical, technical and regulatory teams for submissions.
• Conduct literature searches and critically appraise clinical data.
• Analyze clinical data from investigations and post-market activities.
• Support global submission dossiers and regulatory communications.
• Ensure documentation meets EU MDR, FDA guidance and ISO standards.
• Mentor junior regulatory staff and provide training as needed.
• Contribute to quality control checks of documentation prior to approval.
• Respond to regulatory authorities and Notified Bodies under supervision.

Skills

Technical writing

Clinical evaluation reports

Regulatory submissions

MS Office

Literature reviews

Data analysis

Attention to detail

Independent work

Education

Bachelor’s degree in life science

Masters or PhD level (desirable)

Tools

Endnote

Reference Manager

Adobe Acrobat Pro

Job description

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