Experienced-Biosafety-Specialist

At Ambu, we develop, produce and sell medical devices, which enable doctors and nurses to save lives and improve patient care around the world.

We are now looking for an experienced Biosafety Specialist, who is passionate in driving chemical compliance and define the agenda to continuously support our medical device development and secure our ongoing dedication to a sustainable and biocompatible product portfolio.

Join an innovative team that drives safe and sustainable materials!

As our new colleague in the Biosafety & Sustainability team, you will join a stellar and cohesion-minded team of 6 colleagues in Ballerup, Denmark and 5 colleagues in Penang, Malaysia. When asking people in the team, they add vibrant, healthy feedback culture and a global and inclusive mindset as key words describing the team. Further so, we carry one common goal: to improve patient care and save lives.

You will report to the Head of Biosafety & Sustainability, located in Denmark.

The Global Sustainability & Biosafety function is anchored in R&D - in a tightknit team with a dynamic innovation culture and high team spirit. Our function supports sourcing and assesses materials for our various portfolios and new development projects, ensuring that Ambu's products are biocompatible, whilst paving the way towards being a carbon-neutral company by 2045.

Pioneering happens here.

Ambu has big ambitions for designing sustainable products and are continuously seeking to choose new materials that can improve our environmental impact. For instance, we are the first company in the world to implement bioplastics into an endoscope. To continue our efforts to source new types of sustainable materials we seek a competent team member to ensure that the new materials remain safe and biocompatible. The chemical responsibilities are a major pillar in our sustainability agenda, and this is where you enter the picture.

At Ambu, we have clear roles and responsibilities within our projects and teams, which means that there is a visible link between your results and our growth. Our Global R&D team consists of more than 350 colleagues, located amongst our sites in Ballerup, Augsburg and Penang, with one main objective: to develop new and sustainable products and processes that combine technologies in new and innovative ways, evidently improving patient care and saving lives.

Are you motivated by winning as a team?
In this role, you will be working in multidisciplinary project teams across Ambu’s business areas with different cultures and locations. Two days will most likely not look the same, however, you will frequently:

• Prepare biological evaluation report, toxicological risk assessment, biological equivalence report, FDA 510K submission and material compatibility assessment
• Drive the chemical compliance agenda as Subject Matter Expert in the area
• Follow REACH, RoHS, CLP and global chemical regulation to ensure chemical compliance of Ambu products
• Manage and coordinate biological and chemical testing with external laboratories
• Participate in cross-functional activities related to product safety
• Participate in work with statements, publications and medical marketing documentation to support the devices in the market
• Follow and maintain Ambu’s quality procedures and instructions for biosafety (SOPs)

This job is an on-site position in Ballerup, Denmark with the flexibility to work from home maximum 2 days a week.

As part of your job, you should expect to travel approximately 10-15 days per year as you may attend international conferences, visit other Ambu R&D sites or CROs.

Ideal candidate profile

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

• Hold an MSc or PhD degree in (human) biology, medico or health technology engineering, toxicology - or similar areas, as your experience is what we’re truly interested in!

• Have strong, relevant experience from a medical device or pharmaceutical company – or maybe a relevant National Agency.

• Are familiar with ISO 10993, chemical testing, chemical regulation and material compatibility
• Are a strong communicator and collaborator, with fluency in both Danish and English, given the broad external stakeholder landscape. Our corporate language is English.
• Have experience with chemical testing of medical devices, it’s a plus
• Can translate regulatory requirements into practical and efficient applications

Furthermore, you must be good at prioritizing and planning your tasks, as well as finding yourself to be proactive in searching for knowledge via specialists outside of Ambu, within your own professional network, and from scientific literature. You must be good at initiating and maintaining a wide range of contacts and working together with other specialist groups.

On a personal note, we hope that you are an open-minded and committed team player. You take clear ownership of your responsibilities, and you are motivated by winning as a team. You have a proactive mindset, and you are analytical, structured and capable of digesting complex data, without losing the overall picture.

Application and deadline
You can get more information about the job and about Ambu A/S by contacting Annette Bitz, Head of Biosafety & Sustainability by e-mail at [email protected]. Please expect a delay in your query over the Holiday Season.