Regulatory Medical Writer

Mantra Systems; Sheffield; On-site; GBP 30,000 - 42,000; Full time

Job summary

Mantra Systems in the UK-based core team is seeking a dedicated regulatory writer for medical device submissions. This full-time role involves literature appraisal, writing Clinical Evaluation documents, and preparing technical files under EU MDR, IVDR and FDA.

The successful applicant will join a dynamic, growing regulatory consulting company. Full training will be provided with mentorship and opportunities to tailor the role to your interests and strengths.

Qualifications

• A degree in life sciences 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 (EU MDR/MDR, IVDR, and FDA).
• Ability to grasp new concepts quickly and evaluate scientific data.
• Ability to work efficiently under strict deadlines.
• Can work independently and as part of a team; legally allowed to work in the UK.

Responsibilities

• Conduct systematic literature reviews, appraisal and analysis of published clinical data, and production of literature review reports.
• Contribute towards writing Clinical Evaluation Plans, Clinical Evaluation Reports, and other regulatory documents under supervision of a Lead Medical Writer.
• Contribute towards the development and execution of regulatory strategies for a wide range of clients.
• Work in a dynamic team with a focus on constant improvement and innovation.
• Assist in compiling regulatory affairs policies, changes, and developing training for new procedures when required.
• Collaborate with clients to gather necessary information, understand requirements and address regulatory queries.
• Learn various regulatory frameworks and apply guidance to new products and services.
• Write articles and create content for the company website.

Skills

Regulatory writing

Literature reviews

Clinical data analysis

Regulatory strategy

Documentation drafting

Team collaboration

MS Office

UK work eligibility

Education

Bachelor's degree in life sciences

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, and 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.