Regulatory Affairs Specialist - Urology
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.
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