Experienced Toxicologist to drive chemical compliance at Ambu

Do you want to be part of a truly innovative global company with a purpose of saving patients’ lives? Are you looking for a job with high degree of influence and dynamic working days? Are you experienced in toxicological risk assessment and want to drive chemical compliance at Ambu? And do you want to work in a team spearheading sustainable material choices?

Then this might be your defining moment. Apply today and join us in driving chemical compliance at Ambu #ForeverForward!

We are dedicated to design products that are both safe and sustainable. Are you?

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 a Toxicologist, who is eager to take responsibility in driving chemical compliance activities 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 a Toxicologist, you will be part of the Global Biosafety & Sustainability team, consisting of 6 colleagues in Ballerup, Denmark and 5 colleagues in Penang, Malaysia. 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 innovative 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 still safe, while we are paving the way towards being a carbon-neutral company by 2045. Toxicological risk assessments is a major cornerstone in the process.

Ambu has big ambitions for designing products for sustainability and are continously 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 effort to source new types of sustainable materials we seek a competent team member to ensure that the new materials are still safe and biocompatible.

At Ambu, we have a tradition of fast completion of projects, 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 among our sites in Ballerup, Augsburg and Penang, with one common goal: to develop new 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:

• Drive the chemical compliance agenda, including implementation of toxicological risk assessment standards as Subject Matter Expert in the area
• Be following REACH, RoHS, CLP and global chemical regulation to ensure chemical compliance of Ambu products.
• Manage and coordinate biological and chemical testing with external laboratories
• Prepare biological evaluation report, toxicological risk assessment, biological equivalence report, FDA 510K submission and material compatibility assessment
• 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)
  
  

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

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 toxicology, (human) biology, pharmacology, medico or health technology engineering - or similar areas, as your experience is what we’re truly interested in!
• Can interpret and implement chemical regulations and standards
• Have strong, relevant experience from a medical device or pharmaceutical company – or maybe a relevant National Agency along with experience in ISO 10993, toxicological risk assessment, chemical testing, REACH regulation and material compatibility
• Are a strong communicator and collaborator, as well as fluent in written and oral English
• Having experience with toxicological risk assessment of medical devices is a plus
• Having a European Register of Toxicologists (ERT) title is a plus, but not a requirement
  
  

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 high targets and meeting ambitious timelines. 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].

If you are interested in applying for the position, then please apply as soon as possible as we interview continuously.

Your application will be treated with confidentiality.