Regualtory Consultant

RA Writer, Medical Device Consultant

Location: Remote

Contract: 0.5 FTE, 6-month duration

We’re supporting a fast-moving Med Tech 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.

• 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

• 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