Description
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.