Beschreibung

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 jit0626aen jpiy26aen