Director Regulatory and Quality Assurance
il y a 21 heures
THE COMPANY This innovative MedTech company, part of a renowned French industrial group, specializes in the design, development, and commercialization of FLASH radiotherapy systems. Its mission is to expand the use of radiotherapy in oncology and develop breakthrough treatments for cancer patients. The company is entering a key growth phase and is looking to structure its RA / QA strategy. Reporting directly to the COO, the Director of Regulatory Affairs & Quality Assurance will play a central role in building the quality system, securing ISO 13485 certification, and preparing the first CE marking submission. THE OPPORTUNITY In this strategic leadership role, youll have the opportunity to build and drive the entire RA / QA function from the ground up, with full ownership of ISO 13485 certification and the first CE marking file. Youll work in a collaborative, agile environment that values initiative, impact, and expertise. Take your career to the next level in a mission-driven scale-up backed by a major French industrial group where innovation meets purpose. KEY RESPONSIBILITIES Define the quality and regulatory strategy / KPIs and ensure regulatory compliance. Promote a strong quality and regulatory culture across the organization. Responsible for CE marking and international registrations of medical devices for new products and changes : manage technical documentation and regulatory watch. Act as the main point of contact with Notified Bodies. Serve as Person Responsible for Regulatory Compliance (per Article 15 of MDR 2017 / 745) and as Management Representative (as defined in ISO 13485 and 21CFR820). Oversee the Quality Management System (QMS), HSE policy, and certification audits. Responsible for NC / CAPA and PMS processes. Manage the QARA team. PROFILE Scientific or technical background with a Master's degree (Bac +5). At least 10 years of experience in Quality and Regulatory Affairs within the medical device industry. Strong knowledge of applicable regulatory frameworks for medical devices (ISO 13485, 21CFR820, MDR 2017 / 745). Experience in complex negotiations with Notified Bodies and international competent authorities (Europe, USA, etc.). Fluent in English. Minimum 5 years of experience in team and project management. Strong collaboration skills and ability to work effectively in cross-functional teams. Ability to explain regulatory requirements clearly, and to implement procedures and internal corrective / preventive actions. #J-18808-Ljbffr
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Director, Regulatory
il y a 22 heures
Aix-en-Provence, France Talents Solutions Temps pleinA leading MedTech company in Provence-Alpes-Côte d'Azur is seeking a Director of Regulatory Affairs & Quality Assurance. In this pivotal role, you'll build the RA/QA function from scratch, leading initiatives for ISO 13485 certification and CE marking submissions. The ideal candidate has over 10 years in regulatory affairs within the medical device industry...
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Quality Assurance Engineer
il y a 4 jours
Saint-Macaire-en-Mauges, Pays de la Loire, France Ceva Santé Animale Temps pleinCeva Santé Animale is seeking a Quality Assurance Engineer (M/F) for its FILAVIE site. This permanent position (CDI), starting on December 1st, 2025, is based in Sèvremoine (between Cholet and Nantes).As part of the Quality Department, you will ensure product quality in compliance with GMP standards, in collaboration with other departments. You will also...
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Quality Assurance Engineer
il y a 4 jours
Saint-Macaire-en-Mauges, Pays de la Loire, France CEVA Tiergesundheit GmbH Temps pleinQuality Assurance EngineerThe success of a company depends on the passionate people we partner with.Together, let's share our talents. As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes...
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Training and Quality Coordinator
il y a 1 semaine
Aix-en-Provence, Provence-Alpes-Côte d'Azur, France Voyage Privé Temps pleinCompany Description About Voyage Privé Born in France in 2006, Voyage Privé has grown from an ambitious startup into becoming the Europe's leading travel tech platform. Operating across 9 markets with tens of millions of users, we're not just another e-commerce success story - we're a tech powerhouse revolutionizing online travel. What makes us...
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Training and Quality Coordinator
il y a 2 semaines
Aix-en-Provence, Provence-Alpes-Côte d'Azur, France Voyage Privé Temps pleinAbout Voyage PrivéBorn in France in 2006, Voyage Privé has grown from an ambitious startup into becoming the Europe's leading travel tech platform. Operating across 9 markets with tens of millions of users, we're not just another e-commerce success story - we're a tech powerhouse revolutionizing online travel.What makes us unique? A mission-driven culture...
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Quality Manager
il y a 1 jour
Aix-en-Provence, France Augustinus Bader Temps plein**Responsibilities**: - Responsible for developing AB Supplier Quality Guide, ensuring our Quality requirements are communicated to new and existing suppliers - Provide QA input into supplier qualification program - Oversee and manage the preparation of Quality documents for review/approval and manage through appropriate Quality system - Manage the...
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Training And Quality Coordinator H/F
il y a 4 semaines
Aix-en-Provence, France Voyage Privé Temps pleinYour Mission As a Quality & Training Specialist, you'll play a key role in elevating the performance, expertise, and service quality of our Customer Operations teams. You'll work closely with internal Customer Relations teams, external call-center partners, and cross-functional stakeholders to ensure a seamless and high-quality customer experience while...
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Training and Quality Coordinator F/H
il y a 2 semaines
Aix-en-Provence, Provence-Alpes-Côte d'Azur, France Voyage Privé Temps pleinDescription de l'entreprise About Voyage Privé Born in France in 2006, Voyage Privé has grown from an ambitious startup into becoming the Europe's leading travel tech platform. Operating across 9 markets with tens of millions of users, we're not just another e-commerce success story - we're a tech powerhouse revolutionizing online travel. What...
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Training and Quality Coordinator
il y a 2 semaines
Rue Pascal Duverger, Aix-en-Provence, France Voyage Privé Temps pleinCompany Description About Voyage Privé Born in France in 2006, Voyage Privé has grown from an ambitious startup into becoming the Europe's leading travel tech platform. Operating across 9 markets with tens of millions of users, we're not just another e-commerce success story - we're a tech powerhouse revolutionizing online travel. What makes us...
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Operations Program Management Director
il y a 2 semaines
Aix-en-Provence, France Instapro Group Temps pleinInstapro Group is seeking an experienced Operations Program Management Director responsible for core business operations process, policy, efficiency & alignment with the Product, Tech & UX (PTU) and Marketing departments - and full alignment of the Operations Department with our company mission, vision, values & strategy. If experience is not at the Director...
