EU MDR Regulatory Specialist

Walker Cole International is supporting a medical device organisation in the appointment of a Regulatory Affairs Specialist for an EU MDR project, on a freelance/contract basis.

This consultant will take the lead on a critical MDR transition programme, providing strategic guidance and hands-on regulatory support to ensure compliance for a Class III device.

Key Responsibilities

• Lead the end-to-end EU MDR transition project for a Class III medical device
• Act as the subject matter expert on EU MDR requirements, advising the client on regulatory strategy and implementation
• Guide the development and remediation of technical documentation in line with MDR Annex II & III
• Work closely with the Notified Body to support conformity assessment activities and submissions
• Lead gap assessments against current MDR requirements and define remediation plans
• Ensure compliance with EU MDR (Regulation (EU) 2017/745) and relevant harmonised standards
• Support clinical evaluation activities, including CER updates and clinical strategy alignment
• Oversee risk management documentation in line with ISO 14971
• Provide regulatory input into labelling, IFUs, and UDI requirements
• Collaborate cross-functionally with Quality, Clinical, and R&D teams
• Support audit and inspection readiness activities
• Act as the primary regulatory contact for the project

Requirements

• Proven experience leading EU MDR projects for Class III medical devices
• Strong knowledge of EU MDR requirements and regulatory frameworks
• Experience working directly with Notified Bodies
• Background in orthopaedic devices is highly desirable
• Experience in technical documentation and clinical evaluation reports (CERs)
• Strong understanding of risk management and post-market surveillance requirements
• Ability to work independently and lead client-facing regulatory strategy
• Excellent stakeholder management and communication skills

Working Pattern
Remote (UK/EU-based candidates preferred)

Contract Length – 6 months (part-time, with potential for extension)

Rate – Hourly rate negotiable depending on experience

Regulatory Affairs | EU MDR | Medical Devices | Class III | Notified Body | Technical Documentation | Orthopaedics | Contract | Compliance

Job ID –  100530