UK Regulatory Medical Writer - Clinical Evaluation & Submissions

Mantra Systems Ltd; Sheffield; Hybrid; GBP 32,000 - 42,000; Full time

Benefits offered by this job

Progression routes

Learning opportunities

Access to regulatory events/networking

Job summary

Mantra Systems Ltd in the UK is seeking a full-time regulatory writer to join our core team in Sheffield. You will contribute to literature reviews, Clinical Evaluation submissions, and the preparation of technical files under EU MDR, IVDR and FDA.

No prior regulatory experience is required, but we seek an exceptional life sciences graduate with a 2:1, strong English, and the ability to learn quickly. The role includes full training and mentorship in a supportive, innovative environment.

Qualifications

• Bachelor's degree in life sciences, medical devices or biomedical field with a 2:1 or above.
• Excellent written English with a keen eye for detail.
• A team player with superb verbal communication skills.
• Understanding of international regulatory affairs (EU MDR/MDR, IVDR, FDA).
• Ability to grasp new concepts and evaluate scientific data.
• Ability to work efficiently under strict deadlines.
• Can work independently and as part of the team.
• Legally allowed to work in the UK.
• Proficient in using IT, including Microsoft Office.

Responsibilities

• Conduct of literature reviews and analysis of published clinical data.
• Contribute to writing Clinical Evaluation Plans and Clinical Evaluation Reports.
• Contribute to regulatory strategies for various clients.
• Collaborate with team to improve processes and adapt to regulatory guidance.
• Assist in producing technical documents and regulatory submissions.
• Create content for the company website.

Skills

Strong written English

Team player

Regulatory knowledge

Attention to detail

Independent worker

Time management

IT skills

Clinical literature appraisal

Education

Bachelors in Life Sciences (2:1)

Tools

Microsoft Office

Job description

Mantra Systems Ltd in the UK is seeking a full-time regulatory writer to join our core team in Sheffield. You will contribute to literature reviews, Clinical Evaluation submissions, and the preparation of technical files under EU MDR, IVDR and FDA.

No prior regulatory experience is required, but we seek an exceptional life sciences graduate with a 2:1, strong English, and the ability to learn quickly. The role includes full training and mentorship in a supportive, innovative environment.