Regulatory Medical Writer: Clinical Evaluation Submissions

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

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.