Regulatory Medical Writer

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

We are seeking UK-based applicants for a full-time position in our core team

Join a highly professional and specialised regulatory writing team with a market-leading reputation for the preparation of medical device regulatory submissions for a global client base.

The successful applicant will be part of a dynamic, growing and innovative regulatory consulting company. Work will include appraisal and analysis of published clinical literature and production of literature review reports for inclusion into Clinical Evaluation submissions. Other roles include contributing to the development of a wide range of technical documents, clinical investigation files, and preparation of technical file submissions under EU MDR, IVDR and FDA.

The successful applicant will be encouraged to pioneer improvements to existing processes in a supportive environment that views all ideas, whether implemented or not, as a valuable contribution. With time, you will also have the opportunity to craft your role around your interests and unique skills. A vital attribute is an open, communicative personality that thrives in a mutually supportive and innovative environment.

You must have a Bachelor's degree in a life science field, medical devices or a biomedical science with a grade 2:1 or above. This role does not require prior regulatory experience, but it is demanding, and we need an exceptional person with appropriate qualifications who wants a stimulating career in the medical device regulatory field.

• A degree in a relevant life sciences subject, medical devices, or a 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
• An understanding of international regulatory affairs, including EU MDD/ MDR, IVDR, & FDA
• Ability to grasp new concepts quickly and to understand/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

This role will be office-based, working from the company HQ in Sheffield. While some home-working will be available, it is not open to remote candidates.

Key tasks

• Conduct of systematic literature reviews, appraisal and analysis of published clinical data, and production of literature review reports
• Contribution towards writing of Clinical Evaluation Plans, Clinical Evaluation Reports, and other regulatory documents under the supervision of a Lead Medical Writer
• Contribution towards the development and execution of regulatory strategies for a wide range of clients
• Working in a dynamic team with a focus on constant improvement and innovation
• Assisting in compiling regulatory affairs policies, changes, and developing training for any new procedures when required
• Collaborating with clients to gather necessary information, understand their requirements and address any regulatory queries
• Learning various regulatory frameworks and keeping abreast of ongoing regulatory guidance, as well as applying them in creating new products and services
• Writing articles and creating content for the company website

Full training will be provided, with ongoing mentorship and support from our experienced regulatory writing team.

Our benefits are designed to support both your work and your life outside of it. From practical perks to personal growth opportunities, we aim to make your time with us rewarding, enjoyable, and valuable for your future.

• Progression routes
• Learning opportunities
• Access to regulatory events/ networking

Work environment

• Modern office near Meadowhall
• Free parking
• Air-conditioned office
• Epic coffee machine
• Generous annual leave
• Discretionary bonuses
• Christmas shutdown
• Free fruit

Culture

• Team social events and activities
• Inclusive & friendly environment
• Involvement in business strategy