Regulatory Affairs Specialist - Urology at Phaidon EPM London | Torre
Regulatory Affairs Specialist - Urology
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Regulatory Affairs Specialist - Urology

Phaidon EPM London
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You'll drive global market access for innovative MedTech, shaping the future of urology devices.
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Full-time

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Lyon, France
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Shared by
Julien PETIT
 7 days ago

Requirements and responsibilities

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 ResponsibilitiesLead the preparation and maintenance of regulatory documentation, including GSPR, technical files, and CE markingManage 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 marketsCollaborate cross-functionally with R&D, Quality, and Clinical teams to integrate regulatory requirements early in product developmentEnsure alignment with EU MDR (2017/745) and applicable standardsMaintain regulatory intelligence and proactively assess impact on products and processesContribute to the continuous improvement of QMS proceduresRequirementsStrong expertise in EU MDR 2017/745Proven experience in Regulatory Affairs within medical devicesAbility to analyse and interpret regulatory standards and requirementsHands-on approach with strong documentation and submission experienceExperience interacting with Notified Bodies and regulatory authoritiesFluent in English (French advantageous)ProfileDetail-oriented with a practical, solution-driven mindsetStrong cross-functional collaboration skillsComfortable operating in a fast-paced, innovation-led environmentOpportunityWork on a highly innovative urology device (implantable technology)Direct impact on global product approvals and market expansionJoin a growing, ambitious MedTech environment with strong development potentialIf 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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