Number 1 in nail care in pharmacies in France, Poderm develops naturally effective solutions for foot and nail health. Founded by Maud Falconnet, a podiatrist, Poderm offers unique formulas with patented technology, tested and recommended by healthcare professionals. In a context of growth and international structuring, we are looking for a
Head of Quality & Regulatory Affairs to oversee global compliance, structure the quality system and support product and export development . Reporting to the Management and a member of the Executive Committee, this role will aim to ensure notably: Global regulatory compliance of medical devices (class 1 and 2a), biocidal products, and cosmetics in accordance with current regulations, Optimisation of the quality management system (ISO 13485, transition to MDSAP certification) Export regulatory strategy (Canada / USA and other target markets)
Head of Quality & Regulatory Affairs (medical devices, biocides, cosmetics)
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, updating and maintenance of technical files Manage relations with the Notified Body and health authorities (notifications, audits, inspections) Ensure compliance of labelling and communication materials (MD, biocides) 2. Quality Management System Manage the QMS according to ISO 13485 and applicable requirements Conduct internal and external audits, oversee non-conformities and CAPA Lead certification and maintenance of MDSAP Supervise vigilance activities, complaints and post-market follow-up 3. Support for international development Develop and manage the international regulatory roadmap Define regulatory strategy by market (MD, cosmetics, NHP, biocide) Supervise the preparation and submission of regulatory dossiers for export Support development of markets outside the EU, notably 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 structuring Manage, structure and develop the Quality & Regulatory team (currently 1 person) Manage the QARA activities budget Be a strategic partner for all internal teams (Supply, development, marketing, etc.) and external partners (subcontractors and partners) Ensure proactive international quality and regulatory monitoring
PROFILE 10 to 15 years of experience with dual expertise in quality / regulatory affairs in the medical devices field Proven experience in medical device certification (IIa) Mastery of quality standards (ISO13485, MDSAP) and regulatory (MDR) Regulatory experience in export outside the EU (ideally USA/Canada) Entrepreneurial and business-oriented mindset, able to juggle between strategic vision and operational management Leadership and strong collaborative spirit Fluent in French and English (written and spoken). German is an asset.
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Head of Quality & Regulatory Affairs to oversee global compliance, structure the quality system and support product and export development . Reporting to the Management and a member of the Executive Committee, this role will aim to ensure notably: Global regulatory compliance of medical devices (class 1 and 2a), biocidal products, and cosmetics in accordance with current regulations, Optimisation of the quality management system (ISO 13485, transition to MDSAP certification) Export regulatory strategy (Canada / USA and other target markets)
Head of Quality & Regulatory Affairs (medical devices, biocides, cosmetics)
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, updating and maintenance of technical files Manage relations with the Notified Body and health authorities (notifications, audits, inspections) Ensure compliance of labelling and communication materials (MD, biocides) 2. Quality Management System Manage the QMS according to ISO 13485 and applicable requirements Conduct internal and external audits, oversee non-conformities and CAPA Lead certification and maintenance of MDSAP Supervise vigilance activities, complaints and post-market follow-up 3. Support for international development Develop and manage the international regulatory roadmap Define regulatory strategy by market (MD, cosmetics, NHP, biocide) Supervise the preparation and submission of regulatory dossiers for export Support development of markets outside the EU, notably 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 structuring Manage, structure and develop the Quality & Regulatory team (currently 1 person) Manage the QARA activities budget Be a strategic partner for all internal teams (Supply, development, marketing, etc.) and external partners (subcontractors and partners) Ensure proactive international quality and regulatory monitoring
PROFILE 10 to 15 years of experience with dual expertise in quality / regulatory affairs in the medical devices field Proven experience in medical device certification (IIa) Mastery of quality standards (ISO13485, MDSAP) and regulatory (MDR) Regulatory experience in export outside the EU (ideally USA/Canada) Entrepreneurial and business-oriented mindset, able to juggle between strategic vision and operational management Leadership and strong collaborative spirit Fluent in French and English (written and spoken). German is an asset.
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Hea 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.
