Biocompatibility Specialist (m/f/d)

Biocompatibility Specialist (m/f/d)

Our client is an established, dynamic and internationally successful medical technology company specializing in the development of innovative solutions for intensive care and emergency medicine. These innovations are cutting-edge technologies that enable safer care for critically ill patients. The headquarters, which houses global functions as well as production and development, is in the German-speaking part of Switzerland.

About the role

We are looking for a Biocompatibility Specialist to support the biocompatibility team in the execution of biological evaluations of medical devices throughout the product lifecycle. The role is designed as a supporting and developing expert position, working under the supervision of experienced biocompatibility specialists.

Key activities include biological data analysis, review of material-related information, sample and laboratory coordination, and support of technical and regulatory documentation in accordance with ISO 10993, ISO 14971 / ISO 24971, and applicable EU MDR/MDA and FDA requirements.

Work location, Zürich Area

Your responsibilities

Support of Biocompatibility and Biological Safety

• Support senior team members in the preparation and maintenance of biological evaluation plans and reports according to ISO 10993.
• Analyze biological test data and support clear, structured presentation of results.
• Maintain biocompatibility-related project documentation and records.

Material Data Review

• Review material-related data, such as material data sheets, supplier information, and material compositions, for completeness and consistency in support of biological evaluations.
• Support compilation and maintenance of material documentation relevant for biocompatibility and risk management.
• Prepare material information for further assessment by senior experts.

Sample and Laboratory Coordination

• Coordinate shipment of test samples to external laboratories, including labeling, shipping documentation, and tracking.
• Act as an operational interface to external test laboratories, including scheduling, follow-up, and clarification requests.
• Support the formal review of laboratory reports for completeness and traceability.

Risk Management Support

• Support linkage of biological evaluations to risk management files according to ISO 14971 / ISO 24971.
• Maintain references between biological evaluations, material data, and risk management documentation.

Documentation and Regulatory Support

• Support preparation and updating technical documentation with biocompatibility- and material-related content.
• Prepare documentation packages for audits, inspections, and regulatory submissions.
• Work strictly according to defined procedures, templates, and under expert supervision.

Cross-Functional Collaboration

• Work closely with Senior Biocompatibility Experts and interface with R&D, Design Quality, Regulatory Affairs, Supplier Quality, and Procurement.
• Support internal communication on biocompatibility and material-related topics.

Your profile

• Bachelor’s or master’s degree in chemistry, Biology, Materials Science, Biomedical Engineering, or a related scientific field.
• Up to 3 years of professional experience, preferably in the medical device industry, laboratory environment, or another regulated industry.
• Initial exposure to material data, biological testing, or ISO standards is an advantage but not required.
• Strong interest in biocompatibility, material evaluation, and biological safety of medical devices.
• Careful, structured, and reliable working style with strong attention to detail.
• Good analytical skills and high documentation quality.
• Team-oriented mindset and willingness to grow into a senior expert role.
• Good English skills, written and spoken; German la