Regulatory Affairs Consultant

The Regulatory Affairs Consultant is responsible for leading the company's regulatory affairs activities to ensure compliance with European and international medical device regulations. This role oversees regulatory strategies, submissions, and technical documentation for innovative electromedical devices, supporting product commercialisation and market expansion. Working closely with Quality, R&D, Supply Chain, and Operations, the successful candidate will ensure regulatory compliance throughout the entire product lifecycle while driving operational excellence.

Key Responsibilities

• Develop and execute regulatory strategies for medical devices across European and international markets.
• Prepare, review, and maintain technical documentation in accordance with the EU Medical Device Regulation (MDR) and other applicable regulatory requirements.
• Lead regulatory submissions, registrations, and product filings, including FDA 510(k) submissions.
• Ensure regulatory compliance throughout the product lifecycle, including product modifications and change management activities.
• Coordinate and support validation plans, verification activities, and regulatory documentation requirements.
• Provide critical review and approval of regulatory documentation generated by cross-functional teams.
• Collaborate closely with R&D, Quality Assurance, Supply Chain, Manufacturing, and external partners to support product development and commercialisation.
• Monitor evolving regulatory requirements and implement necessary compliance strategies.
• Support regulatory inspections, notified body interactions, customer audits, and health authority requests.
• Maintain regulatory records and ensure documentation remains inspection-ready.
• Contribute to risk management activities and regulatory assessments throughout product development.
• Provide regulatory guidance to internal stakeholders and promote best practices across the organisation.
• Support international market expansion through timely regulatory approvals and submissions.

Qualifications

• Significant Regulatory Affairs experience within the medical device industry.
• Strong expertise in the EU MDR and technical documentation requirements, proven experience preparing and managing regulatory submissions.
• Experience with FDA 510(k) submissions is highly desirable.