Director of Quality and Regulatory Affairs

JR France; Paris; Sur place; EUR 80 000 - 120 000; Plein temps

Résumé du poste

Une entreprise innovante dans le secteur des dispositifs médicaux recherche un Directeur de la Qualité et des Affaires Réglementaires. Le candidat idéal aura une solide expérience en gestion de la qualité, ainsi qu'une expertise dans les réglementations globales pour les dispositifs médicaux hautement fiables. Ce poste offre des opportunités excitantes pour ceux cherchant à avancer dans leur carrière et à avoir un impact dans l'industrie médicale.

Prestations

Assurance santé complète

Accès à une plateforme de soutien médical avancée

Remboursement de 50% des frais de transport

RTT pour un meilleur équilibre travail-vie

Qualifications

• 5+ années d'expérience en affaires réglementaires et gestion de la qualité pour des dispositifs médicaux de classe III.
• Fluente en français et en anglais (écrit et parlé).
• Capacité à travailler dans un environnement multiculturel et orienté vers l'équipe.

Responsabilités

• Développer et améliorer le Système de Gestion de la Qualité (SGQ) pour maintenir la conformité.
• Gérer les audits internes et externes ainsi que les soumissions réglementaires.
• Conduire des initiatives d'amélioration continue.

Connaissances

Communication

Analytical skills

Problem-solving

Formation

Degree in medicine, pharmacy, engineering, or relevant scientific field

Description du poste

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Director of Quality and Regulatory Affairs, paris

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Client:

Location:

paris, France

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

698577964427221401632761

Job Views:

2

Posted:

06.06.2025

Expiry Date:

21.07.2025

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Job Description:

We are seeking an experienced Director of Quality and Regulatory to support our client in their mission to advance medical technology through innovative neurovascular devices. If you have a passion for leading quality and regulatory teams, ensuring compliance with global standards, and driving the development of high-reliability medical devices, this could be your next challenge.

Responsibilities

• Develop, implement, and improve the Quality Management System (QMS) to maintain compliance with ISO 13485, FDA 21 CFR Part 820, and other global regulations.
• Oversee internal and external audits, including interactions with Notified Bodies, the FDA, and PMDA.
• Manage change control processes, ensuring all product and process modifications are well-documented and compliant.
• Drive continuous improvement initiatives, including CAPA processes, non-conformance management, and risk mitigation.
• Lead regulatory strategy development, ensuring alignment with FDA, MDR (EU), PMDA (Japan), and ISO standards.
• Oversee product verification and validation, ensuring product quality exceeds compliance standards.
• Manage regulatory submissions such as De Novo, CE Marking, and Shonin applications.
• Engage with regulatory authorities, leading Q-Sub meetings with the FDA and Notified Bodies.

Requirements

• Degree in medicine, pharmacy, engineering, or a relevant scientific field.
• 5+ years of experience in regulatory affairs and quality management for high-risk (Class III) medical devices.
• Strong experience in regulatory submissions (EU and/or US) and audits with global regulatory bodies.
• Fluent in French and English (written and spoken).
• Strong communication, analytical skills, and a pragmatic approach to problem-solving.
• Ability to work effectively in a multicultural, team-oriented environment.
• Permanent contract (cadre status) based in the Île-de-France region.
• Reduction of working time (RTT) for improved work-life balance.
• Comprehensive health insurance and access to an advanced medical support platform.
• 50% reimbursement of transport costs.

Your consultant

Taylor Lyons is a Recruitment Consultant at Aspire Life Sciences. He specialises in bridging the gap between talented professionals and leading companies within the Medical Device sector across Europe and the Middle East. With a keen focus on the nuances of Medical Device Regulation (MDR), he brings a strategic approach to recruitment. He ensures that both candidates and organisations are aligned across compliance, skills, and cultural fit.

If this sounds like a role for you or if you are seeking the right addition to your team, contact Taylor at [emailprotected] .