Senior QARA

En Carta Diagnostics is a synthetic biology diagnostic company focused on the development, manufacturing, and commercialization of innovative point-of-need diagnostic devices addressing major unmet medical needs. Our vision: Transforming every smartphone on the planet into a PCR machine, to bring diagnostics for better care, everywhere. Our flagship product, the POCket Lyme kit, is a diagnostic kit used to help patients detect Lyme disease at an early stage, directly at the tick bite, with a first-of-its-kind test accessible through pharmacies and used at home. Our next products are already in development (STIs, emerging threats etc.). We are entering a critical phase, transitioning from R&D to industrialization, regulatory submission and market launch in Europe and the United States. We are looking for a Senior Regulatory & Clinical Affairs Manager to take full ownership of our regulatory and clinical strategy and lead our products from technical file to market authorization. We are a purpose-driven company, guided by strong values : evidence-based
· integrity
· responsibility
· sustainability

Your profile
We are looking for a Senior Regulatory & Clinical Affairs Manager with hands-on experience bringing in vitro diagnostic devices to market under IVDR and FDA pathways. The successful candidate will report directly to the founders. You are rigorous, pragmatic, and able to build a regulatory and clinical path that is both robust and fast. You are comfortable working at the intersection of biology, engineering, clinical , regulatory and market access, you know when a shortcut is acceptable and when it is not, and you enjoy sharing your expertise with a young, ambitious team. Responsibilities You will report jointly to Margot (CTO, co-founder) and Guillaume (CEO, co-founder), and own the regulatory and clinical roadmap of En Carta’s diagnostic devices, from current submissions through launch and into next-generation products. You will work closely with our Quality & Regulatory engineer, who owns the QMS (ISO 13485), and mentor them on regulatory strategy and submissions. Regulatory
• Define and drive the regulatory strategy for Europe (IVDR) and the United States (FDA)
• Own the technical documentation (IVDR Annexes II & III): intended purpose, GSPR, risk management, performance evaluation, labeling and IFU for self-testing
• Own the relationship with our exisiting advisors both in Europe and in the US
• Lead interactions with our Notified Body through conformity assessment devices, including responses to review questions
• Build and execute the FDA pathway (Pre-Submission, 510(k) / De Novo, OTC and POC)
• Anticipate regulatory requirements early in design and support R&D and product teams on design inputs, usability and labeling
• Set up post-market obligations (PMS, PMPF, vigilance)
• Provide support to the marketing team on the marketing material developed Clinical
• Define the clinical strategy and the performance evaluation plan (scientific validity, analytical and clinical performance)
• Design and write clinical performance study protocols (ISO 20916), including comparison against gold-standard methods
• Manage multi-site studies end-to-end: sites, investigators, ethics committees and competent authorities, recruitment, data and reporting
• Select, contract and steer CROs and clinical partners, with a firm hand on quality, timelines and budget
• Write the performance evaluation report and clinical sections of the regulatory submissions
• Coordinate our clinical team and help it grow in autonomy Requirements
• 7+ years in regulatory and/or clinical affairs for medical devices, with a strong IVD focus
• Track record of at least one IVD technical file successfully submitted under IVDR (high-risk class a strong plus)
• Hands-on experience with FDA submissions (510(k), De Novo, Pre-Sub)
• Experience designing and running clinical performance studies from protocol to final report
• Proven experience managing CROs and external clinical partners
• Strong writing, organizational and communication skills; able to explain regulatory constraints clearly to non-specialists
• Comfortable making decisions with incomplete information in a fast-paced startup
• Fluent English (French is a plus) Nice to have: point-of-care, molecular diagnostics or self-testing devices; startup experience; mentoring or managing junior profiles. Deep quality management expertise is not required — our QMS is in good hands. Backgrounds welcome: life sciences, pharmacy, medicine, biomedical engineering, or similar.

We offer
• A full-time position (CDI)
• Real ownership of the regulatory and clinical path of a first-of-its-kind diagnostic, in Europe and the US
• An important seat in a small, deep-tech team
• Competitive salary and benefits
• BSPCE (equity package)
• Flexible work setup (some remote work is an option)
• 100% health insurance coverage
• The opportunity to grow with the company
• Based at Paris Biotech Santé (Cochin), central Paris, surrounded by deep-tech and biotech companies 🔥If you are excited to help bring innovative diagnostic devices from concept to patients, please apply at contact@encarta.bio with your CV and cover letter. En Carta Diagnostics is an equal opportunity employer.