Remote Clinical Affairs Manager - AI Medical Devices

Legit.Health; Madrid; A distancia; EUR 70.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Daycare

Restaurant benefits

Descripción de la vacante

Legit.Health is seeking a Clinical Affairs Manager to own our clinical evaluation and regulatory documentation end-to-end with full technical and scientific confidence. You will work closely with Quality, Regulatory and Product Development teams, but you will not depend on them to lead clinical conversations.

Find, interact with and coordinate a network of consultants and experts to gather specialised insights and solve complex questions.

Formación

• Must have Degree in Medicine, Pharmacy, Biology, Biomedical Engineering, or equivalent.
• 5+ years in clinical trials, regulatory affairs, or medical writing within the medical device industry.
• GCP and quality standards: Software and AI device experience: Direct experience working with software as a medical device (SaMD) or AI-based medical devices.
• Strong command of clinical literature review, clinical data analysis, and basic statistics.
• You can design a SAP, not just read one.

Responsabilidades

• Own clinical evaluation and regulatory documentation end-to-end with technical and scientific confidence.
• Work closely with Quality, Regulatory and Product Development teams, but lead clinical conversations independently.
• Find, interact with and coordinate a network of consultants and experts to gather specialised insights.
• Design and monitor the budget for the clinical evidence department, including forecasting expenditure in clinical research and consultants.
• Manage clinical data and results, ensuring traceability and scientific rigor throughout.
• Author SAPs and SARs.
• Manage updates and change control for CER and PMCF documentation.
• Identify gaps in clinical data and propose structured approaches to address them.

Conocimientos

Clinical trials

Regulatory affairs

Medical writing

SaMD / AI devices

Literature review

SAP / SAR

Clinical data analysis

GCP compliance

English fluency

Documentation management

Educación

Degree in Medicine or related field

Herramientas

EUDAMED

PubMed

Cochrane Library

Regulatory software

GitHub

Descripción del empleo

Legit.Health is seeking a Clinical Affairs Manager to own our clinical evaluation and regulatory documentation end-to-end with full technical and scientific confidence. You will work closely with Quality, Regulatory and Product Development teams, but you will not depend on them to lead clinical conversations.

Find, interact with and coordinate a network of consultants and experts to gather specialised insights and solve complex questions.