Regualtory Consultant

Barrington James Limited; Greater London; Remote; GBP 40,000 - 60,000; Part time

Job summary

A leading recruitment agency in medical devices is seeking a Regulatory Affairs Writer to develop compliant documentation for a MedTech company. The ideal candidate will have experience in Regulatory Affairs and technical writing in a medical device context, with a strong grasp of IFU development and regulatory requirements. This is a remote position on a part-time, 6-month contract.

Qualifications

• Proven experience in Regulatory Affairs, Technical Writing, or Quality Documentation within a medical device or diagnostics company.
• Strong understanding of IFU development and applicable standards (e.g. ISO 20417, ISO 13485, IEC 62366).
• Familiarity with EU MDR, FDA 21 CFR 801, and UKCA documentation requirements.

Responsibilities

• Lead the development and authoring of IFUs in alignment with EU MDR, UKCA, and FDA requirements.
• Compile, organise, and maintain technical documentation to meet regulatory standards.
• Collaborate with cross-functional teams to gather and validate data for technical files.

Skills

Regulatory Affairs

Technical Writing

Quality Documentation

IFU Development

Collaboration

Job description

RA Writer, Medical Device Consultant

Location: Remote
Contract: 0.5 FTE, 6-month duration

We’re supporting a fast-moving MedTech company in the diagnostics space that is looking for a Regulatory Affairs / Technical Documentation Consultant to support the development of compliant and high-quality documentation ahead of upcoming clinical and regulatory milestones.

Key Responsibilities:

• Lead the development and authoring of(IFUs) in alignment with EU MDR, UKCA, and FDA requirements

• Compile, organise, and maintain technical documentation, ensuring it meets applicable regulatory and usability standards

• Collaborate with cross-functional teamsto gather and validate data for inclusion in IFUs and technical files

• Ensure all written materials are clear, accurate, and accessible to the intended end user (e.g. clinicians, patients)

• Support documentation preparation for regulatory submissions and audits

• (Optional/Bonus) Provide input on Software as a Medical Device (SaMD) documentation, if relevant

Ideal Candidate Profile:

• Proven experience in Regulatory Affairs, Technical Writing, or Quality Documentation within a medical device or diagnostics company

• Strong understanding of IFU development, with knowledge of applicable standards (e.g. ISO 20417, ISO 13485, IEC 62366)

• Familiar with EU MDR, FDA 21 CFR 801, and UKCA documentation requirements

• Able to work independently and deliver results in a fast-paced, collaborative environment

• Experience with SaMD is a plus, but not essential