Remote Clinical Trial & Regulatory Lead

Legit.Health; O Consistorio; A distancia; EUR 70.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Fully remote

Flexible compensation: daycare and餐?

Descripción de la vacante

Legit.Health seeks a Clinical Affairs Manager to own clinical evaluation and regulatory documentation end-to-end with technical and scientific confidence in a fully remote environment.

You will coordinate a network of consultants, design SAPs/SARs, manage budgets, ensure data traceability, and collaborate with Quality, Regulatory, and Product Development teams to scale clinical evidence for FDA/CE readiness.

Formación

• 5+ years in clinical trials, regulatory affairs, or medical writing within the medical device industry.
• GCP and quality standards: SaMD or AI-based medical devices experience.
• Strong command of clinical literature review, clinical data analysis, and basic statistics.
• You can design a SAP, not just read one.
• Proficiency with regulatory databases and documentation software.

Responsabilidades

• Own clinical evaluation and regulatory documentation end-to-end.
• Interact with consultants and experts to gather insights and solve complex questions.
• Design and monitor budget for the clinical evidence department, including forecasting expenditure.
• Manage clinical data and results with traceability and scientific rigor.
• Author SAPs and SARs; update CER and PMCF documentation.
• Identify gaps in clinical data and propose structured approaches to address them.

Conocimientos

Clinical trials

Regulatory affairs

Medical writing

Data analysis

English proficiency

Educación

Degree in Medicine, Pharmacy, Biology, Biomedical Engineering, or equivalent

Herramientas

EUDAMED

PubMed

Cochrane

Regulatory documentation software

GitHub

Descripción del empleo

Legit.Health seeks a Clinical Affairs Manager to own clinical evaluation and regulatory documentation end-to-end with technical and scientific confidence in a fully remote environment.

You will coordinate a network of consultants, design SAPs/SARs, manage budgets, ensure data traceability, and collaborate with Quality, Regulatory, and Product Development teams to scale clinical evidence for FDA/CE readiness.