Regulatory Specialist

MDR Technical File Remediation Contractor Contract: 6–12 months IR35: Outside IR35 Location: Remote Start: ASAP / flexible I'm supporting a medical device organisation looking for an experienced MDR Technical File Remediation Contractor to support a significant regulatory remediation programme. The role

• Review and remediate existing EU MDR technical documentation / technical files
• Identify compliance gaps and develop appropriate remediation plans
• Update technical documentation in line with EU MDR 2017/745
• Work closely with Regulatory Affairs, Quality, Clinical and Engineering teams
• Support technical documentation through internal review and regulatory submission
• Ensure documentation is complete, consistent and audit-ready Experience required
• Strong hands-on experience with EU MDR Technical File remediation
• Previous experience working with medical device technical documentation
• Good understanding of MDR requirements and applicable guidance/standards
• Ability to work independently and manage multiple technical files
• Previous consultancy/contract experience is advantageous 6–12 month contract | Outside IR35 | Fully remote If you are available or know a strong MDR Technical File specialist who may be interested, please get in touch for further details.