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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.
Job Responsibility:
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, including writing Reprocessing Plans and Reports
Support material selection, change control, and product development to ensure biocompatibility and reprocessing considerations are proactively managed
Provide support in equivalence assessments towards previous generations of devices
Interface with external testing laboratories and review study protocols and results
Mentor junior team members and serve as the internal subject matter expert
Requirements:
Master’s degree or PhD in Biology, Biomedical Engineering, Toxicology, Biochemistry, or similar
Experience working with ISO 10993‑1 and ISO 17664
Good writing skills within a regulatory and scientific context
Ability to work cross‑functionally and drive decisions in a fast-paced environment
Nice to have:
Knowledge of or experience with Risk Management in accordance with ISO 14971
Experience with audit participation
What we offer:
An attractive healthcare package to keep you fit and well
Breakfast every day, and a delicious and healthy lunch cooked by our private chefs
Good work/life balance e.g., flexible work from home policy