Quality Manager m / w / d - remote möglich

Perifit; Paris; À distance; EUR 70 000 - 90 000; Plein temps

Résumé du poste

Une startup en pleine expansion dans le domaine de la Femtech recherche un Head of QARA pour garantir la conformité réglementaire et la qualité de ses produits tels que les dispositifs d'entraînement du plancher pelvien. Ce poste stratégique implique la gestion d'une équipe et la collaboration avec plusieurs départements pour intégrer la qualité dans le développement de produits. Les candidats doivent avoir plus de 7 ans d'expérience dans le domaine des dispositifs médicaux, avec une solide formation en ingénierie.

Prestations

Couverture santé complète financée à 100% par l'entreprise

Bureaux spacieux au cœur de Paris

Qualifications

• 7+ années d'expérience en affaires réglementaires et en assurance qualité pour dispositifs médicaux.
• Au moins 3 ans dans un poste de gestion.
• Expérience en production de masse et connaissance des normes internationales.

Responsabilités

• Diriger les efforts réglementaires et d'assurance qualité.
• Améliorer la qualité de production et réduire les retours clients.
• Collaborer avec R&D, Fabrication et Chaîne d'approvisionnement.

Connaissances

Gestion de la qualité

Conformité réglementaire

Communication claire

Rédaction technique

Formation

Diplôme d'ingénieur en Engineering ou Affaires réglementaires

Description du poste

Our Mission ️ Perifit is a profitable and fast-growing femtech startup based in Paris, France. Our team grew from 2 co-founders to approximately 40+ employees in three years (2020 to 2025), and we operate in a truly global environment, with customers and partners around the world. At Perifit, we stand for equality, inclusivity, benevolence and wellbeing for both our clients and our employees. Joining Perifit means being part of a dynamic, mission-driven team that is making a real difference in women's lives, and having the opportunity to contribute to a growing and innovative startup in the Femtech industry ! As we expand our product portfolio, enter new markets, and continuously improve our solutions, we need to strengthen our Quality and Regulatory processes. We need to ensure compliance of the product while remaining easy to manufacture, high-quality, and customer-friendly. We are looking for a solid and pragmatic leader to manage multiple products across diverse markets efficiently. As our Head of QARA, you will be the strategic and operational leader ensuring regulatory compliance, product quality, and smooth market access for our pelvic floor trainers and breast pumps in Europe (Class I) and the US (Class II under FDA 510(k)). Your mission will be to drive regulatory submissions, ensure ISO 13485 compliance by implementing quality processes that balance efficiency and compliance. With your expertise, we can continue delivering trusted, high-quality solutions that positively impact women's health worldwide. &##You will lead regulatory and quality assurance efforts to ensure Perifit’s products comply with international standards while maintaining customer satisfaction. You will improve production quality and reduce customer returns through post-market surveillance and CAPA processes. Maintaining and refining our ISO 13485-certified QMS, you will ensure regulatory and quality processes remain efficient and adaptable. As the leader of the QARA team, you will foster a compliance culture while avoid unnecessary bureaucracy. You will collaborate with R&D, Manufacturing, and Supply Chain teams to integrate compliance and quality into product development and production. Educational Background : An engineering degree in Engineering or Regulatory affairs. Relevant Experience : 7+ years of experience in Regulatory Affairs & Quality Assurance for medical devices, ideally in electronic medical devices (Class I preferred). At least 3 years with a management position. Fluent in English, with strong technical writing skills and clear communication abilities. Experience in Mass Production : You have worked with companies manufacturing products at scale and understand the challenges of ensuring quality and compliance in high-volume production. Global Regulatory Exposure : You are familiar with international regulatory frameworks such as TGA Australia, Health Canada, or other regional standards, enabling smoother market access. Mandarin Proficiency : Comprehensive Health Coverage : Excellent mutual health insurance (Alan) 100% financed by the company. &##Spacious offices in the heart of Paris with a welcoming atmosphere. Keywords : Head of QARA, Regulatory Affairs, Quality Assurance, Medical Devices, ISO 13485, FDA 510(k), Risk Management, Femtech.

Quality Manager • Paris, Paris (75); Ile-de-France, France