Clinical Project Leader

Job Summary

Quantum Surgical is looking for a Clinical Project Leader to join a team of creative and energetic people who are building the next generation of smart tools for minimally invasive therapies.

The Clinical Project Leader is directly responsible of the Clinical Evaluation and Post Market Clinical monitoring. The candidate should have demonstrated experience in driving clinical studies in a regulated environment. He/She works closely with R&D, Quality and Regulatory Affairs as well as the Project Manager.

Key Responsibilities

  • Establish the Clinical Evaluation Report in compliance with MEDDEV 2.7.1.
  • Drive pre-clinical trials on animal.
  • Drive clinical trials for pre-CE marking.
  • Collect data and consolidate files for pre-clinical and clinical trials and studies.
  • Coordinate and monitor the implementation of trials and studies with partners.
  • Analyze data, write and issue clinical reports.
  • Manage budget with the finance department.
  • Ensure compliance with regulatory requirements and quality procedures.
  • Implement preparation and realization of post CE marking clinical studies.
  • Ensure relationships with service providers and monitor results.
  • Contribute to the scientific watch of existing clinical data or clinical studies to design.
  • Provide clinical data to support the company‚Äôs strategy.

Experiences and Qualifications

  • Ms Engineering (biomedical, sciences) or equivalent.
  • Strong knowledge of clinical best practices and standards for clinical trials and studies (ISO 14155).
  • 5+ years of experience in the management of clinical studies or clinical trials organization within the medical device industry.
  • Experience of Quality Management System and Design Control.
  • Knowledge of main standards (ISO 13485, ISO 14971, IEC 62366, FDA, 21 CFR 820).
  • Ability to work in multidisciplinary teams.
  • Strong analytical and problem-solving skills.
  • Excellent communication and documentation skills.
  • Pragmatic and customer-oriented approach.
  • Fluent in spoken and written English.

Desired Experience

  • Knowledge of the medical device industry and constraints of OR and interventional radiology rooms