Biocompatibility Specialist Medical Devices

Project overview

For our client in the medical technology sector, we are looking for a Biocompatibility / Biological Evaluation Specialist - Medical Devices from January 2027 onwards in the greater Mannheim area.

Project details

from January 2027

Until the end of December 2027 (with option for extension)

Greater Mannheim area and remote

Full-time

Description

Profile

• You will create and maintain Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER) in accordance with ISO 10993-1 and EU MDR.
• You will review existing biological evaluations, identify potential gaps, and derive suitable testing and evaluation strategies.
• You will commission and manage external testing laboratories and review the created test plans as well as the resulting results.
• You will assess material, supplier, and process changes regarding their potential impact on the biological safety and biocompatibility of medical devices.
• You will support risk management according to ISO 14971 and participate in the creation and updating of technical documentation.
• You will support design control and change control processes regarding biological and regulatory issues.
• You will act as a technical contact person for topics related to Biological Evaluation and Biocompatibility during audits and with Notified Bodies.
• You will coordinate closely with Quality, Regulatory Affairs, suppliers, external testing laboratories, and toxicologists.
• You have a degree in Chemistry, Biochemistry, Biology, Pharmacy, Biomedicine, or a comparable scientific qualification.
• You have practical experience in creating or reviewing BEPs and BERs for medical devices.
• You have sound knowledge of ISO 10993, especially ISO 10993-1, as well as ISO 14971, ISO 13485, and EU MDR.
• You have experience in selecting, commissioning, and technically managing external testing laboratories.
• You can technically assess biological evaluations and test results and place them within the context of technical documentation and risk management.
• You have very good English skills, both written and spoken, and can confidently handle regulatory and technical documentation.
• You have experience with polymers, consumables, or dental products.
• You have knowledge of chemical characterization and toxicological risk assessment according to ISO 10993-17 and ISO 10993-18.
• Ideally, you possess a qualification as an internal auditor according to ISO 13485.
• Start: 2027-01
• Duration: 12 Monate
• Remote: hybrid
• Location: Hessen, Deutschland, DE
• Languages: German, English