Preclinical R&D Biocompatibility and Cytotoxicity Specialist H/F

KARPOS RH is recruiting on behalf of one of its clients, an R&D center specializing in the development of medical devices and innovative healthcare technologies, for an R&D Preclinical Specialist – Biocompatibility and Cytotoxicity.

Reporting to the Research & Innovation Director, you will join the team to support one of the company’s strategic clients in the development of innovative healthcare solutions.

As the technical expert in biological safety assessment, biocompatibility, and cytotoxicity, you will contribute to the development, scientific validation, and regulatory approval of innovative technologies in the field of dental medical devices and biomaterials.

Key Responsibilities :

• Develop Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs) in accordance with the requirements of ISO 10993.
• Perform biological safety assessments based on a risk management approach for both existing and newly developed products.
• Design, coordinate, and analyze cytotoxicity studies in compliance with ISO 10993-5 and other applicable standards.
• Contribute to R&D innovation projects involving new dental materials and technologies.
• Prepare, review, and maintain biological safety documentation for international regulatory submissions.
• Manage relationships with testing laboratories and external scientific partners.

Profil

We are looking for candidates with a Master’s degree or PhD in Toxicology, Biology, Biomedical Sciences, Biomedical Engineering, Materials Science, Chemistry, Pharmacology, or a related scientific discipline.

The ideal candidate has at least five years of experience in biocompatibility, toxicology, preclinical research, or medical device development. You have a strong understanding of the biological safety requirements for medical devices, including ISO 10993 standards, cytotoxicity testing, risk management according to ISO 14971, as well as FDA and EU MDR regulatory requirements.

Beyond your technical expertise, you are recognized for your perseverance, efficiency, and strong analytical skills, with the ability to solve complex scientific challenges. Excellent communication, negotiation, and stakeholder management skills are essential to collaborate effectively with internal teams, partner laboratories, and external scientific experts.