We are actively looking to recruit a Preclinical Studies Manager will be a key element in the execution of our pre-clinical strategy, ensuring that we collect pre-clinical data with the required quality and at the right quality to support program strategy and regulatory submissions.

The Preclinical Studies Manager will report to the Head of Preclinical. The position is based in Paris, France.

Principal Duties and Responsibilities

• Coordinate regulatory preclinical development studies, focused on the assessment of medical devices safety and performance in relevant animal models
• Ensure that study design and strategy meets program requirements through close interaction with different departments (e.g. New Concepts, Product Development, Quality, Regulatory, etc)
• Manage all preclinical operational aspects for assigned programs to ensure timely delivery of key data to inform project decisions and program milestones (availability of test items, contracts, budget, timelines, protocol development, study monitoring, data review, reporting, and study closure)
• Oversee the progress of the study, ensuring that the study is conducted, recorded, and reported according to the study protocol and ensures that the study is compliant with the appropriate regulations
• Managing the selection and outsourcing of studies to CROs
• Participate in internal and supplier audits

Qualifications and Skills

• MS degree in engineering or sciences;
• 3+ years experience in Pre-clinical studies for regulatory submissions, preferably within the medical device industry
• Good understanding of various standards and associated requirements including ISO 13485, ISO 14971, ISO 10993, and Good Laboratory Practices (GLP)
• Experience selecting and managing CRO relationships
• Project management experience
• Good team skills and ability to work in an interdisciplinary and international environment
• Excellent oral and written communication skills (English & French)

Job Competencies/Personal Attributes

• Excellent leadership skills;
• Great communication and presentation skills;
• Autonomy and ‘Can do’ attitude;
• Hands-on approach;
• Good organizational skills
• Strong proactivity and problem-solving capabilities.