Jobs in Solihull, United Kingdom
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Regualtory Consultant
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
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.
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
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
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.
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