Senior Regulatory & Clinical Lead – IVD Diagnostics, Equity

En Carta Diagnostics; Paris; Ibrido; EUR 90.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Full health insurance

Equity (BSPCE)

Flexible work setup

Growth opportunity in deep-tech team

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Regulatory affairs

Clinical affairs

Regulatory strategy

FDA submissions

IVDR

CRO management

English fluent

Formazione

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

Strumenti

QMS knowledge

ISO 13485

Descrizione del lavoro

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.