Head of Quality & Regulatory Affairs

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, 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 lead 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 have the objective of ensuring, 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 passage), Export regulatory strategy (Canada/USA and other target markets). Head of Quality & Regulatory Affairs (medical devices, biocides, cosmetics) MISSIONS 1. Medical device and biocide regulatory affairs 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 Lead 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. Accompanying international development Elaborate and lead the international regulatory roadmap, Define the regulatory strategy by market (MD, cosmetic, NHP, biocide), Supervise the constitution and submission of regulatory files for export, Accompany the development of non-EU markets, particularly USA/Canada. 4. Accompanying 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), Lead 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 watch. 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, Fluent French and English (written and spoken), German is an asset. jpid3eba9b0jm jpit0626jm jpiy26jm