Head of Quality & Regulatory Affairs (dispositifs médicaux, biocides, cosmétiques)

• 02 July 2026 • 100% • Indeterminate duration • Possible • Chemin du Pré Fleuri 1-3, 1228 Plan-les-Ouates • Log in to see the salary estimate on jobup.ch Number 1 in nail care in pharmacies in France, Poderm develops naturally effective solutions for foot and nail health. Founded by Maud Falconnet, a podologist, Poderm offers unique formulas with patented technology, tested and recommended by health professionals. In a context of growth and international structuring, we are looking for a Head of Quality & Regulatory Affairs to drive global compliance, structure the quality system, and support product development and export. Attached to the Management and a member of the Management Committee, this role will aim to ensure, in particular: • Global regulatory compliance of medical devices (class 1 and 2a), biocidal products, and cosmetics in accordance with current regulations, • Optimization of the quality management system (ISO 13485, MDSAP certification) • Export regulatory strategy (Canada/USA and other target markets) Head of Quality & Regulatory Affairs (dispositifs médicaux, biocides, cosmétiques) MISSIONS 1. Regulatory affairs for medical devices and biocides • Define and deploy the regulatory strategy for medical devices (EU - class 1 and 2a) and other product statuses (biocides, cosmetics) • Supervise the creation, update, and maintenance of technical files • Manage relationships with the Notified Body and health authorities (notifications, audits, inspections) • Ensure compliance with labeling and communication media (MD, biocides) 2. Quality Management System • Pilot the QMS according to ISO 13485 and applicable requirements • Conduct internal and external audits, supervise non-conformities and CAPA • Carry out certification and maintenance of MDSAP • Supervise vigilance, complaint, and post-market surveillance activities 3. Support for international development • Develop and pilot the international regulatory roadmap • Define the regulatory strategy by market (MD, cosmetics, NHP, biocides) • Supervise the constitution and submission of regulatory files for export • Support the development of markets outside the EU, particularly USA/Canada 4. Support for product development • Integrate quality and regulatory requirements from the upstream phases of development projects • Contribute to development roadmaps with a pragmatic and business-oriented approach 5. Leadership and structuring • Manage, structure, and develop the Quality & Regulatory team (1 person today) • Pilot the QARA activity budget • Be a strategic partner for all internal teams (Supply, development, marketing, etc.) and external teams (subcontractors and partners) • Ensure proactive international quality and regulatory monitoring PROFILE • 10 to 15 years of experience with dual quality/regulatory expertise in the field of medical devices • Confirmed experience in medical device certification (IIa) • Mastery of quality (ISO13485, MDSAP) and regulatory (MDR) references • Regulatory experience in exporting outside the EU (ideally USA/Canada) • Entrepreneurial spirit and business-oriented, with the ability to juggle between strategic vision and operational management • Leadership and strong collaborative spirit • French and English fluent (written and spoken). German is an asset. *