Senior Clinical Affairs Manager, SaMD (Remote)

Legit.Health; Lugo; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Legit. Health is seeking a Clinical Affairs Manager to own clinical evaluation and regulatory documentation end-to-end for EU and FDA submissions.

You will design CEPs and CERs, lead audits with notified bodies, and build the evidence base independently, collaborating with Quality, Regulatory and Product Development teams. This fully remote role involves budgeting, data management, PMCF planning, literature reviews, and regulatory dossiers, translating insights to Product and Medical Science

Formación

• Degree in Medicine, Pharmacy, Biology, Biomedical Engineering, or equivalent; GCP certification essential.
• 5+ years in clinical trials, regulatory affairs or medical writing within the medical device industry.
• Experience with MDR and/or FDA regulatory frameworks.
• Knowledge of submission-ready CER writing and analysis.
• Strong English writing and literature review capabilities.

Responsabilidades

• Design CEPs and CERs in full regulatory compliance across EU and US.
• Lead clinical audits with notified bodies and authorities.
• Coordinate consultants and experts for insights.
• Budget design and forecasting for the clinical evidence department.
• Manage clinical data with traceability and scientific rigor.
• Author SAPs and SARs.
• Design and execute PMCF plans and reports.
• Conduct systematic literature reviews with methodological discipline.
• Prepare Dossiers for regulatory submissions (FDA 510(k) etc).
• Develop evidence strategies compliant with EU MDR and FDA.
• Translate clinical evidence into actionable product team insights.
• Identify gaps in clinical data and propose solutions.

Conocimientos

English proficiency

Autonomous execution

Regulatory documentation

Scientific literature review

Project management

SaMD / AI familiarity

Educación

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

GCP certification

RAPS certification

Master's in Regulatory Affairs

Herramientas

EUDAMED

PubMed

Cochrane

Regulatory documentation software

Descripción del empleo

Legit. Health is seeking a Clinical Affairs Manager to own clinical evaluation and regulatory documentation end-to-end for EU and FDA submissions.

You will design CEPs and CERs, lead audits with notified bodies, and build the evidence base independently, collaborating with Quality, Regulatory and Product Development teams. This fully remote role involves budgeting, data management, PMCF planning, literature reviews, and regulatory dossiers, translating insights to Product and Medical Science