Head of Quality Affairs and Regulatory Affairs | Permanent Contract
il y a 5 jours
OverviewLa missionThe company :Hepta Medical is a French medical device company developing an minimally-invasive treatment for lung cancer. Their device is a flexible microwave ablation probe which can be introduced in the patient’s lung through the airway to locally ablate and destroy the tumor. During the procedure, their system is capable of locally measuring the temperature to monitor the size of the ablation zone, resulting in safer and more efficient treatments.After successfully raising its SERIES A, the company is expanding its team to initiate its clinical operations.Your missionsYou will work in direct relationship with the CEO and will have a ° view of all key project of the company. Your main tasks will be to :Lead the QMS deployment and maintenance, identifying gaps and non-conformities, and training internal teamsControl key suppliers and updating agreements in accordance with the product developmentDraft requests and preparing meetings with FDA and Notified Bodies in collaboration with their regulatory consultantsLead the preparation of the technical documentation and related documents for the clinical trial and regulatory submissionsWork in close partnership with the CEO, the VP R&D, and HEPTA’s partners (contract manufacturers, CRO, regulatory advisors) to ensure fast and agile product delivery in compliance with regulatory requirements in US and EuropeSupport the CEO in grant applicationsWhat they can offerExciting growth opportunities within a fast-growing, high-potential companyThe chance to contribute to a highly ambitious project with real-world impactA tight-knit, passionate team – like a small family – with strong cohesion and mutual supportInspiring managers eager to help you grow fast, both technically and personallyA truly international environment, with clinical trials across EuropeThe profile they\'re looking forEngineering degree (ideally from a top-tier school) with a specialization in QARA / Regulatory Affairs5 / 10+ years of experience implementing QMS compliant with EU MDR, ISO, 21 CFR, and related standardsProven experience with Class IIb / III medical devices in a clinical context, and a solid understanding of regulatory and clinical requirementsExcellent level of EnglishStrong analytical and organizational skills, autonomous, fast learner with an entrepreneurial mindset, and an excellent team fitProcessus d\'embaucheFirst interview with a recruiterSecond interview with the CEOA take-home technical test (2 / 3h)Presentation of the test results, with an on-site visit to meet the whole team (half a day) #J-18808-Ljbffr
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Head of Quality Affairs and Regulatory Affairs | Permanent Contract
il y a 2 semaines
Suresnes, France Hepta Medical Temps pleinLa mission The company: Hepta Medical is a French medical device company developing an minimally-invasive treatment for lung cancer. Their device is a flexible microwave ablation probe which can be introduced in the patient’s lung through the airway to locally ablate and destroy the tumor. During the procedure, their system is capable of locally measuring...
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Regional Patient Affairs Director
il y a 5 jours
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il y a 5 jours
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Global Patient Affairs Director Neurology
il y a 5 jours
Suresnes, Île-de-France SERVIER Temps pleinDate de parution: 31 oct. 2025Ville: SuresnesPays/Région: FRType de contrat: CDIN° offre: 10265Global Patient Affairs Director NeurologyWe are a human-scale, international, and independent pharmaceutical group governed by a Foundation. Our unique model makes us proud and, more importantly, enables us to fully serve our mission: "committed to therapeutic...
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Global Patient Affairs Director Neurology
il y a 5 jours
Suresnes, Île-de-France SERVIER MONDE Temps pleinWe are a human-scale, international, and independent pharmaceutical group governed by a Foundation. Our unique model makes us proud and, more importantly, enables us to fully serve our mission: "committed to therapeutic progress for the benefit of patients."In R&D, we also focus on creating new medicines that slow down or halt the progression of rare...
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Global Director, Neurology Patient Affairs
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Suresnes, France Servier Group Temps pleinAn international pharmaceutical organization is seeking a Global Patient Affairs Director – Neurology to drive patient engagement strategies related to rare neurological disorders. Ideal candidates will have at least 7 years of leadership experience in patient advocacy and a strong background in neurology. Responsibilities include defining project...
