Regulatory Medical Writer - Medical Devices

Regulatory Medical Writer – Medical Affairs

A well respected and industry recognised medical device regulatory consultancy is looking for a Regulatory Medical Writer to join their Regulatory and Medical Affairs team, developing the highest quality scientific content for a broad range of projects.

The Company

A renowned regulatory consulting company known for their expertise in preparing medical device regulatory submissions for a diverse global clientele.

Regulatory Medical Writer

This fantastic opportunity is centred on writing comprehensive literature review reports for incorporation into Clinical Evaluation submissions. Additionally, you will contribute to the development of various technical documents, clinical investigation files, and the preparation of regulatory submissions compliant with EU MDR, IVDR, and FDA requirements. This is a beautifully varied role where you’ll collaborate on multiple projects and engage in conferences and external meetings as required.  

The ideal candidate will have:

• Bachelor's degree in a relevant scientific discipline (e.g., life sciences, biomedical engineering).
• Prior experience in regulatory writing within the medical device industry is highly desirable.
• Proficient understanding of regulatory requirements, including EU MDR, IVDR, and FDA regulations.
• Strong analytical skills with the ability to critically appraise clinical literature.
• Excellent written and verbal communication skills.
• The ability to work collaboratively in a dynamic team environment.
• Proactive mindset with a passion for innovation and process improvement.
• Open and communicative personality conducive to a supportive work environment.

You’ll get to work in a beautiful office environment in Sheffield with a close knit, dynamic, welcoming, fun and passionate team.  

You will receive a competitive salary, excellent bonus and benefits along with the opportunity to develop your skills in a dynamic and varied role and work with an ambitious and highly rewarding company.  The role will be a mix of home and office working with the requirement to visit the company’s office 3 days per week. .

If this sounds like the role for you, please apply now!