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Clinical Evaluation Specialist

vor 4 Monaten

BielBienne, Schweiz Bien-Air Surgery SA Vollzeit
Bien-Air Surgery SA is a growing international company which develops, manufactures, and markets high-tech instruments for microsurgery. We have held an enviable position in the international market for many years thanks to our emphasis on invention and innovation, and the high quality of our products and services.

To join our Regulatory Affairs team, we are seeking a highly skilled and experienced :

CLINICAL EVALUATION SPECIALIST

Job Description:

As a Clinical Evaluation Specialist, you will play a crucial role in ensuring the clinical safety and performance of our medical devices.

Your responsibilities will include:

Clinical Evaluation:

- Coordinating clinical evaluations with internal and external experts - Developing and managing clinical evaluation plans and reports (CEP, CER) - Conducting comprehensive systematic literature reviews on relevant medical devices and clinical practices - Ensuring timely submission of clinical study reports to regulatory authorities - Effectively managing audits for clinical aspects by notified bodies and competent authorities

Post market clinical follow-up (PMCF):

- Defining, implementing, and monitoring the PMCF plan in collaboration with key stakeholders - Authoring and managing the PMCF report

Profile:

- 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

Location:

- This position can be based in our Biel/Bienne and/or in Le Noirmont office.

Our Benefits:

- 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