Clinical Evaluation Expert

As a Clinical Evaluation Specialist at Bien-Air Surgery SA, you will play a crucial role in ensuring the clinical safety and performance of our medical devices.

Your responsibilities will include:

• Coordinating clinical evaluations with internal and external experts to ensure compliance with regulatory requirements.
• Developing and managing clinical evaluation plans and reports (CEP, CER) to support product development and market authorization.
• Conducting comprehensive systematic literature reviews on relevant medical devices and clinical practices to inform product design and development.
• Ensuring timely submission of clinical study reports to regulatory authorities to maintain product compliance.
• Effectively managing audits for clinical aspects by notified bodies and competent authorities to ensure regulatory compliance.

• Defining, implementing, and monitoring the PMCF plan in collaboration with key stakeholders to ensure ongoing product safety and performance.
• Authoring and managing the PMCF report to document product performance and identify areas for improvement.

• Advanced degree in a relevant scientific field (e.g., medicine, pharmacy, life sciences).
• Proven experience in clinical evaluation, systematic research of scientific literature, medical writing, and post-market surveillance in the medical device industry.
• In-depth knowledge of relevant regulatory requirements (ISO 13485, MDR 2017/745, MDSAP, FDA, etc.).
• Experience in Class III medical devices would be a plus.
• Strong analytical and statistical skills.
• Excellent written and verbal communication skills.
• Fluency in English, any other languages such as French or German is a plus.

• Friendly, collaborative work environment in a family setting.
• Variety of assignments.
• Opportunity to contribute directly to the company's results and success.
• Development and career opportunities.
• Flexible working hours.