Remote Clinical Affairs Lead, MedTech Regulatory Strategy

Legit.Health; Ourense; Presencial; EUR 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Full-remote position

Flexible compensation: daycare and餐

Flexible vacation policy

Flexible working hours

Permanent contract

Competitive salary according to your经验

Descripción de la vacante

Legit.Health is hiring a Clinical Affairs Manager to own clinical evaluation and regulatory documentation end-to-end. You will lead CEP/CER development across EU and US markets and build the evidence base for regulatory submissions.

You will work closely with Quality, Regulatory, and Product teams to shape clinical strategy while remaining independent in conversations. The role requires 5+ years in clinical trials or regulatory affairs within medical devices, with GCP and RAPS certifications

Formación

• Must have GCP certification.
• RAPS certification or actively in progress.
• Experience: 5+ years in clinical trials, regulatory affairs, or medical writing within the medical device industry.

Responsabilidades

• Design and implement CEP and CER in full compliance with EU and US regulatory requirements.
• Lead clinical audit processes with notified bodies and regulatory authorities.
• Coordinate a network of consultants and experts for insights and solutions.
• Design and monitor budget for the clinical evidence department and forecasting.
• Author SAPs and SARs; design PMCF plans and reports.
• Prepare regulatory submissions including FDA 510(k).
• Translate clinical evidence into actionable insights for Product and Medical Science teams.
• Identify data gaps and propose structured approaches to address them.

Conocimientos

GCP certification

RAPS certification

Clinical trials

Regulatory affairs

Medical writing

Educación

Degree in Medicine

Degree in Pharmacy

Biology

Biomedical Engineering

Descripción del empleo

Legit.Health is hiring a Clinical Affairs Manager to own clinical evaluation and regulatory documentation end-to-end. You will lead CEP/CER development across EU and US markets and build the evidence base for regulatory submissions.

You will work closely with Quality, Regulatory, and Product teams to shape clinical strategy while remaining independent in conversations. The role requires 5+ years in clinical trials or regulatory affairs within medical devices, with GCP and RAPS certifications