Remote Senior Clinical Affairs Lead - SaMD/MedTech

Legit.Health; O Consistorio; Presencial; EUR 60.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work.

Flexible compensation: daycare and餐厅

Descripción de la vacante

Legit.Health is hiring a Clinical Affairs Manager to own clinical evaluation and regulatory documentation end-to-end, with leadership in EC/US submissions. You will craft CEP/CER, oversee PMCF, and build the evidence base while guiding regulatory conversations with QA/Regulatory and Product teams.

You will design and defend evidence strategies for MDR and FDA, translate findings to product teams, and manage multi-geography dossiers with autonomy and scientific rigor.

Formación

• Degree in Medicine, Pharmacy, Biology, Biomedical Engineering, or equivalent.
• GCP certification required.
• RAPS certification required or in progress.
• Master's in Regulatory Affairs recommended.
• 5+ years in clinical trials, regulatory affairs, or medical writing in the medical device industry.

Responsabilidades

• Design and implement Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) per EU and US regulatory requirements.
• Lead clinical audit processes with notified bodies and authorities.
• Coordinate with consultants and experts for insights.
• Manage clinical data with traceability and scientific rigor.
• Author SAPs and SARs and PMCF plans and reports.
• Prepare submissions including FDA 510(k) dossiers.

Conocimientos

Clinical evaluation

Regulatory affairs

Medical writing

GCP

Data analysis

Literature review

English proficiency

Educación

Medicine, Pharmacy, Biology, Biomedical Engineering degree or equivalent

Herramientas

EUDAMED

PubMed

Cochrane

Descripción del empleo

Legit.Health is hiring a Clinical Affairs Manager to own clinical evaluation and regulatory documentation end-to-end, with leadership in EC/US submissions. You will craft CEP/CER, oversee PMCF, and build the evidence base while guiding regulatory conversations with QA/Regulatory and Product teams.

You will design and defend evidence strategies for MDR and FDA, translate findings to product teams, and manage multi-geography dossiers with autonomy and scientific rigor.