Head of Quality and Regulatory Affairs, Diagnostics

Porté par la passion d'améliorer la qualité de vie, WS Audiology se positionne comme un leader essentiel du marché des appareils auditifs. Notre ambition ? Répondre aux besoins d’un marché des soins auditifs mal desservi et transformer notre organisation pour toucher un public plus large, avec une efficacité et une inclusivité accrue. Cette personne dirigera la gestion de la qualité globale et la conformité réglementaire pour une division Software as a MedicalDevice (SaMD), en veillant à la sécurité, à l’efficacité et à l’alignement réglementaire tout au long du développement, des opérations et des activités post-commercialisation. What you will do Define and drive global QMS and regulatory strategy (ISO 13485, 21 CFR 820, EU MDR/IVDR, etc.). Oversee QMS operations: document control, CAPA, change control, deviations, training, internal audits, supplier quality, and management review. Manage risk management per ISO 14971 and post-market surveillance, including field actions and recalls. Govern product lifecycle QA/QC: design controls, software as SaMD, cybersecurity considerations, and supplier qualification. Ensure data integrity; uphold audit readiness and regulatory inspections. Partner cross-functionally with R&D, Manufacturing and Commercial; foster a quality-driven culture. Lead and develop the QA/RA team (2); manage budget and resources. Report metrics and progress to executives; support quality-by-design and risk-based decision-making. Ensure compliance with ISO 13485, EU MDR 2017/745, US FDA and other global regulatory requirements. Drive QMS improvement initiatives in collaboration with stakeholders. What you bring Experience 7+ years in QA/RA in medical devices, with leadership experience if possible. Minimum 5 years of experience in a Quality department within the Medical Devices sector. Proficiency with MDR 2017/745, NF EN ISO 13485 standards. Advanced degree in a relevant field (engineering, life sciences) or equivalent experience. Deep knowledge of ISO 13485, 21 CFR 820, and EU MDR/IVDR; experience with SaMD and IVDs a plus. Personal competencies A people-oriented person who is always looking for solutions and bringing quality improvements, with a “can-do” attitude. Digital savvy and able to provide innovative thinking and develop disruptive approaches. Solid, positive communicator (verbal and written) and collaborator. Able to develop and maintain positive relationships with employees, boards, officials, regulatory agencies, and other stakeholders. Self-motivated, demonstrating a bias for action and positive role model leadership. Demonstrates credibility, self-determination and a sense of ownership and urgency in their responsibilities. Organized and able to work independently, managing complex projects in a dynamic and fast-paced environment. Who we are At WSA, we provide innovative hearing aids and hearing health services. Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world. With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes. Sounds wonderful? We can't wait to hear from you. WSA is an equal‑opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self. Cela vous inspire ? Nous avons hâte de vous rencontrer #J-18808-Ljbffr