Clinical Affairs Lead, Brain Microrobotics IDE

Robeaute; Paris; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Robeauté seeks a Clinical Affairs Project Manager to lead GLP preclinical and early clinical studies for a microrobotic brain platform. You will manage regulatory submissions (IDE/FDA), coordinate CROs, and collaborate with surgeons and the Head of Clinical to drive study design and reporting.

The role emphasizes cross-disciplinary teamwork, high scientific integrity, and effective communication in English, with French preferred. Open to candidates across EMEA, based in a suitable location.

Qualifications

• MD/PhD or equivalent work experience in relevant areas.
• At least 5 years experience in preparation and execution of clinical trials with medical devices, incl GLP and IDE.
• Experience with device testing in lab and clinical environments.
• Strong written and spoken English; French preferred.

Responsabilités

• Plan and coordinate GLP preclinical and clinical studies with surgeon collaborators.
• Prepare documentation for ethics committees and regulatory submissions (IDE, FDA).
• Contract clinical study sites and manage CRO selection/contracts.
• Oversee GLP preclinical and clinical study management and reporting.
• Collaborate with surgeons on study design and execution; data collection and reporting.
• Contribute to conferences, medical communications, and publication support.

Connaissances

English communication

Clinical trial coordination

Formation

MD or PhD in Life Sciences or Biomedical Engineering

Description du poste

Robeauté seeks a Clinical Affairs Project Manager to lead GLP preclinical and early clinical studies for a microrobotic brain platform. You will manage regulatory submissions (IDE/FDA), coordinate CROs, and collaborate with surgeons and the Head of Clinical to drive study design and reporting.

The role emphasizes cross-disciplinary teamwork, high scientific integrity, and effective communication in English, with French preferred. Open to candidates across EMEA, based in a suitable location.