Biocompatibility Specialist Medical Devices

Project overview

For a leading medical technology company, we are looking for an experienced Biocompatibility Specialist to support the area of Biological Evaluation and regulatory compliance.

Your tasks include the creation and maintenance of Biological Evaluation Plans (BEP) and Reports (BER) according to ISO 10993-1 and EU MDR. You will review existing biological evaluations, identify gaps, and develop suitable testing strategies. Commissioning and technical management of external testing laboratories are also part of your responsibilities, as is the assessment of material, supplier, and process changes regarding biological safety.

You will support risk management according to ISO 14971, accompany design and change control processes, and act as a technical contact person for audits and with Notified Bodies. Close collaboration with Quality, Regulatory Affairs, suppliers, and external toxicologists is essential.

A completed degree in Chemistry, Biochemistry, Biology, Pharmacy, or Biomedicine is required. You bring practical experience in creating BEP/BER and have sound knowledge of ISO 10993, ISO 14971, ISO 13485, and EU MDR. Experience in selecting and managing testing laboratories and very good English skills are required.

Experience with polymers, consumables, or dental products, knowledge in chemical characterization and toxicological risk assessment, as well as a qualification as an internal auditor according to ISO 13485 are advantageous.

Project details

Greater Mannheim area with remote options. Full-time position for 12 months with an option to extend.

January 2027.

• Start: 04.01.2027
• Duration: 12 Monate
• Remote: hybrid
• Location: Mannheim, DE
• Languages: German, English