Head of Quality Affairs and Regulatory Affairs | Permanent Contract
il y a 1 semaine
La 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 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 missions: You 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 teams Control key suppliers and updating agreements in accordance with the product development Draft requests and preparing meetings with FDA and Notified Bodies in collaboration with their regulatory consultants Lead the preparation of the technical documentation and related documents for the clinical trial and regulatory submissions Work 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 Europe Support the CEO in grant applications What they can offer: Exciting growth opportunities within a fast-growing, high-potential company The chance to contribute to a highly ambitious project with real-world impact A tight-knit, passionate team – like a small family – with strong cohesion and mutual support Inspiring managers eager to help you grow fast, both technically and personally A truly international environment, with clinical trials across Europe The profile they're looking for: Engineering degree (ideally from a top-tier school) with a specialization in QARA / Regulatory Affairs 5/10+ years of experience implementing QMS compliant with EU MDR, ISO , 21 CFR, and related standards (ISO , ISO , ISO ) Proven experience with Class IIb/III medical devices in a clinical context, and a solid understanding of regulatory and clinical requirements Excellent level of English Strong analytical and organizational skills, autonomous, fast learner with an entrepreneurial mindset, and an excellent team fit Processus d'embauche First interview with a recruiter Second interview with the CEO A take-home technical test (2/3h) Presentation of the test results, with an on-site visit to meet the whole team (half a day)
-
Suresnes, France Hepta Medical Temps pleinOverviewLa 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...
-
Regulatory Affairs Coordinator Zone Latam
il y a 7 jours
Suresnes, France Spot On Sp. z o.o Temps pleinPrimary Responsibilities Within our site of Suresnes (France) - Contributes to recruitment of the staff dedicated to these projects/programs in the Hub/Platform zone - Ensures delivery of regulatory activities by the Hub/Platform zone, on assigned programs/ projects. Serves as the senior contact for regulatory issues (backed up by regulatory colleagues as...
-
Global Patient Affairs Director
il y a 2 semaines
Suresnes, France Servier Temps plein**Date de parution**:3 oct. 2024**Ville**:Suresnes**Pays/Région**:FR**Type de contrat**:CDI**N° offre**:7022Global Patient Affairs Director - Oncology - Nous sommes un groupe pharmaceutique à dimension humaine, international et indépendant, gouverné par une Fondation. Notre modèle, singulier, fait notre fierté mais, surtout, nous permet de servir...
-
Global Patient Affairs Director Neurology
il y a 3 jours
Suresnes, France Servier Group 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...
-
Regional Patient Affairs Director
il y a 4 jours
Suresnes, Île-de-France SERVIER Temps pleinDate de parution: 31 oct. 2025Ville: SuresnesPays/Région: FRType de contrat: CDIN° offre: 10266Regional Patient Affairs Director - LATAM RegionWe 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...
-
Regional Patient Affairs Director
il y a 4 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."As a global leader in cardiology, we aim to become a focused and innovative player in oncology by...
-
Global Patient Affairs Director Neurology
il y a 4 jours
Suresnes, Île-de-France Servier France 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...
-
Global Patient Affairs Director Neurology
il y a 4 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...
-
Global Patient Affairs Director Neurology
il y a 4 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...
-
Global Director, Neurology Patient Affairs
il y a 3 jours
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...
