Regualtory Consultant

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 teams to 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

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

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