Senior Biosafety Specialist

Job description

About the Role We are looking for a Senior Biosafety Specialist to join our team of nine dedicated Systems Engineers to support our 3D scanners throughout their lifecycle. As a Senior Biosafety Specialist, you will play a key role in ensuring the biological safety, cleanliness, and compliance of our medical devices. You will partner closely with Product Creation, Regulatory Affairs, Scientific Affairs, Manufacturing, and external testing laboratories to define biological evaluation strategies, assess risks, and ensure compliance with relevant global standards and regulations. As our Senior Biosafety Specialist, you will lead biological assessments for new and existing medical devices in accordance with ISO 10993-1 and related parts of the ISO 10993 series. The role also encompasses device cleanliness and reprocessing in accordance with ISO 17664 and applicable guidance. Key Responsibilities: Be responsible for creating the Biological Evaluation Plans (BEPs) as well as the Biological Evaluation Reports (BERs) based on results received from accredited external test laboratories. Provide subject matter expertise on device cleanliness and reprocessing requirements following ISO 17664,...