Number 1 in nail care in pharmacies in France, Poderm Head of Quality & Affairs (medical devices, biocides, cosmetics) Number 1 in nail care in pharmacies in France, Poderm X effective solutions for foot and nail health. Founded by Maud Falconnet, podiatrist, Poderm X has unique formulas, with patented technology, tested and recommended by health professionals. In a growth context, we are looking for a Head of Quality & Affairs to drive overall compliance, structure the X system, and support product and export development. Reporting to management and a member of the Executive Committee, this role will aim to ensure in particular: The overall regulatory compliance of medical devices (class 1 and 2a), biocides, and cosmetics according to the requirements of the X quality system (ISO, MDSAP transition) Export regulations (Canada / USA and other target markets) Head of Quality & Affairs (medical devices, biocides, cosmetics) RESPONSIBILITIES 1. Regulatory affairs for medical devices and biocides Define and deploy the regulations for medical devices (EU - class 1 and 2a) and other products (biocides, cosmetics) Supervise the updating and maintenance of technical files Manage audits, inspections with the X Organization and health authorities Ensure compliance of labeling and supports (MD, biocides) 2. X Quality System Manage the X QMS ISO and applicable requirements Conduct internal and external audits, supervise non-compliances and CAPA Ensure the establishment and maintenance of MDSAP Supervise vigilance activities and post-market monitoring 3. Supporting development and managing the regulatory roadmap per market (MD, cosmetics, NHP, biocide) Oversee the creation and submission of regulatory files for export Support the development of non-EU markets, especially USA / Canada 4. Product development support Integrate quality and regulatory requirements from the early phases of development projects Contribute to development roadmaps with a business-oriented approach 5. Leadership and structuring and developing the Quality & Regulatory team (1 person today) Manage the budget for QARA activities Be a partner for all internal teams (Supply, development, marketing, etc.) and external partners (subcontractors and partners) Ensure proactive quality and regulatory monitoring PROFILE 10 to 15 years of experience with dual competence in quality / regulatory affairs in the field of medical devices Proven experience in medical devices (IIa) Mastery of quality (ISO, MDSAP) and regulatory (MDR) standards Regulatory experience in export outside the EU (ideally USA/Canada) Fluent in French and English (written and spoken). German is a plus, entrepreneurial and business-oriented, capable of juggling between vision and management, and with a strong spirit. Position based in Geneva - to be filled as soon as possible: Full-time permanent contract. jidbff833daen jit0311aen jpiy26aen