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Biocompatibility Expert (M/F/D)
Tasks:
Support the planning and execution of biocompatibility activities for existing medical devices in accordance with applicable regulations and standards (e.g. ISO 10993)
Perform gap assessments of existing biocompatibility documentation to ensure compliance with EU MDR and FDA 510(k) requirements
Prepare and update technical documentation, including:
Biological Test Plans (BTP)
Biological Evaluation Plans (BEP)
Biological Risk Assessments (BRA)
Biological Evaluation Reports (BER)
Toxicological Risk Evaluation documentation
Supporting documentation for regulatory submissions
Contribute to the preparation of documentation required for regulatory submissions
Coordinate and communicate with external testing laboratories regarding biocompatibility activities
Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle
Qualification:
Bachelor's or Master's degree in Biomedical Engineering, Biology, Toxicology, Life Sciences, Materials Science, or a related discipline (PhD preferred)
Several years of experience in biocompatibility for medical devices
Strong knowledge of the ISO 10993 series, biological evaluation, and biological risk assessment
Experience preparing and maintaining biocompatibility documentation for EU MDR and FDA 510(k) submissions
Familiarity with technical documentation related to biological safety and toxicological risk evaluation
Experience working with external testing laboratories
Excellent technical writing and documentation skills
Fluent English, both written and spoke
Requirements:
Start: asap; latest 15.7.
Duration: 9 months
Capacity: 35h/Wo
Location: 100% remote
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