Senior Clinical Affairs Manager, SaMD (Remote)

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

Ventajas ofrecidas por este puesto de trabajo

Permanent contract

Fully remote position

Flexible working hours

Descripción de la vacante

Legit. Health is seeking a Clinical Affairs Manager to own clinical evaluation and regulatory documentation end-to-end, acting as the expert in the room for European and US submissions.

The role requires leading CEP/CER development, post-market follow-up, and regulatory strategy with cross-functional teams. You will design and defend our clinical evidence approach, work with MDR and FDA frameworks, and ensure high scientific rigor across clinical data, literature reviews, and SAP/SAR

Formación

• 5+ years in clinical trials, regulatory affairs, or medical writing within the medical device industry.
• Demonstrated MDR and/or FDA regulatory framework experience and ability to build submissions.
• GCP knowledge and ISO standards familiarity (GCP and ISO).
• Experience with SaMD or AI-based medical devices and clinical literature review.

Responsabilidades

• Design and implement CEPs and CERs in full compliance with EU and US requirements.
• Lead clinical audits with notified bodies and regulatory authorities during certification.
• Coordinate with consultants and experts to gather insights for complex questions.
• Forecast expenditure for the clinical evidence department including clinical research and consultants.
• Manage clinical data and results ensuring traceability and scientific rigor.
• Author SAPs and SARs and design PMCF plans and reports.
• Conduct systematic literature reviews with methodological discipline.
• Prepare CER/PMCF documentation updates and change control.
• Prepare clinical dossiers for regulatory submissions including FDA 510(k).
• Develop clinical evidence strategies across EU MDR and US FDA frameworks.
• Translate clinical evidence into insights for Product and Medical Science teams.
• Identify data gaps early and propose structured approaches to address them.

Educación

Degree in Medicine, Pharmacy, Biology, Biomedical Engineering

RAPS Certification

Master's in Regulatory Affairs (recommended)

Herramientas

EUDAMED

PubMed

Cochrane Library

Regulatory documentation software

Descripción del empleo

Legit. Health is seeking a Clinical Affairs Manager to own clinical evaluation and regulatory documentation end-to-end, acting as the expert in the room for European and US submissions.

The role requires leading CEP/CER development, post-market follow-up, and regulatory strategy with cross-functional teams. You will design and defend our clinical evidence approach, work with MDR and FDA frameworks, and ensure high scientific rigor across clinical data, literature reviews, and SAP/SAR