Regulatory Medical Writer

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.

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 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

Essential requirements

As a minimum, 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 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 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.

Career

• Progression routes
• Mentorship and training
• Learning opportunities
• Access to regulatory events/ networking

Work environment

• Modern office near Meadowhall
• Free parking
• Air-conditioned office
• Epic coffee machine

Well-being

• 35-hour working week
• Flexible working (WFH Thursdays)
• Generous annual leave
• Discretionary bonuses
• Christmas shutdown
• Free fruit

Culture

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