Regulatory Affairs Specialist - Urology

Location: France
Sector: Medical Devices

Overview

We are partnering with an innovative MedTech company developing a next-generation electromechanical urology device, supporting global market access for a flagship product. They are seeking a Regulatory Affairs Specialist to drive regulatory compliance, manage submissions, and support international expansion.

Key Responsibilities

• Lead the preparation and maintenance of regulatory documentation, including GSPR, technical files, and CE marking
• Manage regulatory submissions and act as key contact for Notified Bodies and Competent Authorities (including Q&A processes)
• Support global market access activities, ensuring compliance across key international markets
• Collaborate cross-functionally with R&D, Quality, and Clinical teams to integrate regulatory requirements early in product development
• Ensure alignment with EU MDR (2017/745) and applicable standards
• Maintain regulatory intelligence and proactively assess impact on products and processes
• Contribute to the continuous improvement of QMS procedures

Requirements

• Strong expertise in EU MDR 2017/745
• Proven experience in Regulatory Affairs within medical devices
• Ability to analyse and interpret regulatory standards and requirements
• Hands-on approach with strong documentation and submission experience
• Experience interacting with Notified Bodies and regulatory authorities
• Fluent in English (French advantageous)

Profile

• Detail-oriented with a practical, solution-driven mindset
• Strong cross-functional collaboration skills
• Comfortable operating in a fast-paced, innovation-led environment

Opportunity

• Work on a highly innovative urology device (implantable technology)
• Direct impact on global product approvals and market expansion
• Join a growing, ambitious MedTech environment with strong development potential

If you are looking to play a hands-on, high-impact regulatory role within an innovative urology business, we would be keen to speak with you. Please apply or get in touch directly to discuss this opportunity further.