Regulatory Medical Writer

Job description

Join a highly professional and specialised regulatory writing team with a market-leading reputation for 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 focus primarily on 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 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 aspect is an open, communicative personality that thrives in a mutually contributive environment.

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 supervision of a Lead Medical Writer
• Contribution towards the development and execution of regulatory strategies for various projects
• 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
• Collaborate with clients to gather necessary information, understand their requirements and address any regulatory queries they may have
• Learning various regulatory frameworks and ongoing regulatory guidance, as well as applying them in creating new products and services
• Writing articles and creating content for the company website

Essential requirements

You must have a Bachelor's degree in a life science field, medical devices or a biomedical science with 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 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, FDA, and other regulations
• Ability to grasp new concepts quickly and to understand / evaluate scientific data
• Ability to work efficiently under strict deadlines
• Can work independently and as a 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, this role is not open to remote candidates.

Benefits

• The role offers fantastic exposure to the medical device industry
• Competitive salary and bonus + 3% employer pension contribution
• Collaborative and supportive work environment
• Contribution to meaningful projects that impact healthcare innovation

Full training will be provided and the successful applicant will work under the direct supervision of the Senior Regulatory Specialist.