Senior QARA - Regulatory & Clinical

En Carta Diagnostics; Paris; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Full health insurance

Equity (BSPCE)

Flexible work setup

Growth opportunity in deep-tech team

Job summary

En Carta Diagnostics in Paris is seeking a Senior Regulatory & Clinical Affairs Manager to own regulatory and clinical strategy for IVDR and FDA pathways, guiding products from technical file to market authorization.

You will lead cross‑functional teams across biology, engineering and quality, build robust regulatory routes, and ensure timely, compliant submissions while helping a young, ambitious team scale.

Qualifications

• 7+ years in regulatory and/or clinical affairs for medical devices with IVDR focus.
• Experience submitting IVDR technical files and FDA submissions (510(k), De Novo, Pre-Sub).
• Strong writing, project management and cross-functional collaboration.

Responsibilities

• Define regulatory and clinical strategy for Europe (IVDR) and the US (FDA).
• Lead technical documentation and post-market obligations; coordinate with QA on QMS.
• Manage multi-site clinical studies, CROs and partners from protocol to report.
• Prepare regulatory submissions and clinical evaluation reports.

Skills

Regulatory affairs

Clinical affairs

Regulatory strategy

FDA submissions

IVDR

CRO management

English fluent

Education

Science background (life sciences, pharmacy, medicine, biomedical engineering)

Tools

QMS knowledge

ISO 13485

Job description

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

En Carta Diagnostics is an equal opportunity employer.