Number 1 in nail care in pharmacies in France, Poderm develops effective solutions for foot and nail health. Founded by a podiatrist, Poderm offers unique formulas with patented technology, tested and recommended by healthcare professionals.In a context of growth, we are looking for a Head of Quality & Affairs to drive global compliance, structure the quality system, and support product development and export. Reporting to Management, and a member of the Executive Committee, this role will aim to ensure:The global regulatory compliance of medical devices (class 1 and 2a), biocidal products, and cosmetics in accordance with regulations.The management of the quality system (ISO 13485, MDSAP transition).The regulatory management of exports (Canada / USA and other target markets).Head of Quality & Affairs (medical devices, biocides, cosmetics)MISSIONS1. Regulatory affairs for medical devices and biocides- Define and deploy the regulatory strategy for medical devices (EU – class 1 and 2a) and other products (biocides, cosmetics).- Supervise the update and maintenance of technical files.- Manage relations with the Notified Body and health authorities (audits, inspections).- Guarantee the compliance of labeling and marketing materials (MD, biocides).2. Quality Management System- Manage the QMS according to ISO 13485 and applicable requirements.- Conduct internal and external audits, supervise non-conformities and CAPA.- Lead the implementation and maintenance of MDSAP.- Supervise vigilance activities and post-market surveillance.3. Support for development and export- Pilot the regulatory roadmap by market (MD, cosmetic, NHP, biocide).- Supervise the compilation and submission of regulatory dossiers for export.- Support the development of non-EU markets, particularly USA / Canada.4. Support for product development- Integrate quality and regulatory requirements from the early stages of development projects.- Contribute to development roadmaps with a pragmatic and business-oriented approach.5. Leadership and management- Structure and develop the Quality & Regulatory team (1 person currently).- Manage the QARA budget.- Be a partner to all internal teams (Supply, development, marketing, etc.) and external teams (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.- Confirmed experience in the certification of medical devices (IIa).- Mastery of quality standards (ISO 13485, MDSAP) and regulatory standards (MDR).- Regulatory experience in export outside the EU (ideally USA/Canada).- Entrepreneurial and business-oriented spirit, with the ability to juggle strategic vision and operational management, and a strong team spirit.- Fluent French and English (written and oral). German is a plus. jid3eba9b0aen jit0728aen jpiy26aen
Head of Quality and Regulatory Affairs Arbeitgeber: Poderm
Poderm est un employeur exceptionnel qui valorise l'expertise et l'innovation dans le domaine des soins des ongles. Situé à Genève, notre entreprise offre un environnement de travail dynamique où la collaboration et le développement professionnel sont au cœur de notre culture. Nous proposons des opportunités de croissance continue, des formations régulières et un cadre de travail stimulant, idéal pour les professionnels passionnés par la qualité et la réglementation des dispositifs médicaux.
