Senior Biosafety Specialist

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, 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.

Required Qualifications

• 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.

Preferred Qualifications

• Knowledge of or experience with Risk Management in accordance with ISO 14971

• Experience with audit participation

Join us in shaping a company culture that makes Monday mornings worth it.

We are an exciting, visionary, and international place to work. But most of all, we are a diverse group of over 50 different nationalities who all contribute to an awesome company culture. We partake in social clubs, monthly Friday and various in-team activities as well. If that’s not enough, then add on:

• 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.

• A joint purpose: to enable dentists to provide superior dental care to every patient, every time.

We encourage all relevant applicants to apply. We are committed to celebrating human diversity, and we trust that the best way to reach outstanding business results, is by welcoming diverse people into our community.

About us

3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Twenty years later, 3Shape has 2,000+ employees globally. With the help of dental professionals and amazing colleagues we’re creating award-winning scanning and CAD/CAM solutions to change dentistry together! Together, we contribute to a better world. Experience the everyday #lifeat3Shape across the globe on LinkedIn.