Regualtory Consultant
- Horley, Surrey
- Permanent
- Full-time
Contract: 0.5 FTE, 6-month durationWe'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 requirementsCompile, organise, and maintain technical documentation, ensuring it meets applicable regulatory and usability standardsCollaborate with cross-functional teams to gather and validate data for inclusion in IFUs and technical filesEnsure 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 relevantIdeal Candidate Profile:Proven experience in Regulatory Affairs, Technical Writing, or Quality Documentation within a medical device or diagnostics companyStrong 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 requirementsAble to work independently and deliver results in a fast-paced, collaborative environmentExperience with SaMD is a plus, but not essential