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 360° 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 13485, 21 CFR, and related standards (ISO 62304, ISO 60601, ISO 14971)
• 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