Remote Clinical Affairs Manager — SaMD & Regulatory

Legit.Health; Vitoria; Presencial; EUR 65.000 - 95.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible compensation: daycare

Remote work

Permanent contract

Descripción de la vacante

Legit.Health is seeking a Clinical Affairs Manager to own clinical evaluation and regulatory documentation end-to-end. You will collaborate with Quality, Regulatory, and Product Development teams while coordinating external consultants to solve complex questions.

You will manage clinical data, forecast budgets, and author SAP and SAR with a focus on SaMD and AI-based medical devices. A fully remote setup is offered, with flexible compensation options for daycare and meals.

Formación

• 5+ years in clinical trials, regulatory affairs, or medical writing within the medical device industry.
• GCP and quality standards knowledge with SaMD or AI-based devices experience.
• Strong skills in clinical literature review and data analysis.

Responsabilidades

• Own clinical evaluation and regulatory documentation end-to-end.
• Coordinate with Quality, Regulatory and Product Development teams.
• Find and coordinate consultants for specialized insights.
• Design and monitor budget for the clinical evidence department.

Conocimientos

Clinical affairs

Regulatory knowledge

Biostatistics

English (Advanced)

Educación

Medicine

Pharmacy

Biology

Biomedical Engineering

Herramientas

EUDAMED

PubMed

Cochrane

Regulatory software

Descripción del empleo

Legit.Health is seeking a Clinical Affairs Manager to own clinical evaluation and regulatory documentation end-to-end. You will collaborate with Quality, Regulatory, and Product Development teams while coordinating external consultants to solve complex questions.

You will manage clinical data, forecast budgets, and author SAP and SAR with a focus on SaMD and AI-based medical devices. A fully remote setup is offered, with flexible compensation options for daycare and meals.