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Senior Biocompatibility Specialist

We are currently partnering with BK Medical, an innovative ultrasound medical device company looking to recruit a Senior Biocompatibility Specialist to join their newly established team R&D Reprocessing and Biocompatibility in Copenhagen.

As a Senior Biocompatibility Specialist, you will perform the biological evaluations and plan the activities managing the biological and chemical testing at contract laboratories. This also includes writing the biological evaluation reports, ensuring that communication of scientific data is done in a structured way. You will support and add value to the R&D projects and registration of devices, being the go-to person and Subject matter Expert within biocompatibility and toxicology.

Preferably you have experience with ISO 10993 standards, biological and chemical testing of medical devices, and in preparing biological evaluation documentation. Knowledge in toxicology, or with reprocessing and sterilization methods, or with REACH and ROHS regulations is a benefit. You are used to working in an international setting, in a profound engineering setting and a dynamic environment, where your knowledge within biocompatibility is crucial.

Key responsibilities include:

The Senior Biocompatibility Specialist for BK Medical will be a vital person in a team of four, working with biocompatibility and validation of methods for cleaning, disinfection, and sterilization of BK products. You will contribute with your knowledge within biocompatibility, toxicology and various test methods in R&D innovation projects and projects on implementing new methods for cleaning, disinfection and sterilization. You thrive with responsibility and have the courage to learn new complex areas while applying your knowledge and experience on biocompatibility and toxicology.

Requirements:

– Master’s or bachelor’s degree in Pharmacy, Chemical Engineering or related
– Experience with biocompatibility and/or toxicology – ISO 10993 standards
– Experience in biological and chemical testing for devices
– Good understanding of R&D processes for medical devices.
– Detail oriented and structured
– Driven and positive personality
– Pragmatic and systematic
– Used to work in an international environment

Why?

BK Medical has a unique technology within ultrasound and few competitors in the market.

Driven by an expansive strategy BK Medical is expanding into new and exciting business areas using the newest technologies – from AI, Robotics and machine learning. BK Medical has a global footprint with 650 employees in USA and close to 200 employees in DK – representing the full value chain- from Development – Production and Sales.

How?

For further information do reach out to Head of Recruitment Ida Wenger-Parving on 2633 4301. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.

Read more about Senior Biocompatibility Specialist here!