Do you want to be part of a global and truly innovative company with headquarters in Denmark? Are you looking for a job with a high degree of influence and a varied working day? Do you have a background within human biology and toxicology from the medical device or pharmaceutical industry? And are you passionate about ensuring biocompatibility and biological safety of medical devices?

Ambu is looking for a Biosafety Specialist who is eager to take responsibility and drive the necessary biosafety activities to continuously support our medical devices and securing our ongoing dedication to quality products.

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

You will join the growing Global Clinical Affairs consisting of 25 colleagues divided into: Clinical Research, Post Market Clinical Development, Clinical Operations and Biosafety. 21 of us are based at Ambu Headquarters in Ballerup, Denmark and 4 colleagues are based at our site in Penang, Malaysia. As Biosafety Specialist you will be a part of the Global Biosafety team consisting of 3 colleagues in Ballerup, Denmark and 3 colleagues based at our site in Penang, Malaysia. You will report directly to the Head of Biosafety located in Denmark.

Working independently and in project teams
This newly established position within the area includes working in multidisciplinary project teams across Ambu’s business areas with different cultures and locations.
Your main responsibilities will be to:
• Manage and coordinate biocompatibility and chemical characterisation testing
• Prepare biological evaluations, toxicological risk assessments, and material compatibility evaluations
• Participate in cross-functional activities related to product safety
• Participate in work with statements, publications and medical marketing documentation to support the device in the market
• Follow and maintain Ambu’s quality procedures and instructions for clinical research and biosafety (SOPs)
• Stay updated within the fields of international regulatory demands, relevant biosafety areas, and biological evaluations.

As a part of your job, you should expect to travel approximately 20 days per year as you may attend international conferences, visit other Ambu R&D sites or CRO’s.

Relevant background within human biology and toxicology
You hold an MSc within human biology, toxicology, pharmacology, medico or health technology engineering or similar areas. You have 2-5 years of relevant experience from a medical device or pharmaceutical company and experience with biological evaluations, toxicological assessments, chemical testing, and materials interactions is a plus.
As a person, 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. It is a must that you understand the importance of documentation.

You are a strong communicator. We expect you to have excellent cooperation and communication skills, and that you are fluent in written and oral English. Danish language skills are an additional advantage.

As this is a very independent job, you must be good at prioritizing, planning and completing your tasks. Furthermore, it is important that you are proactive in searching knowledge via specialists outside of Ambu, within your own professional network, and from the scientific literature. You must be good at initiating and maintaining a wide range of contacts, and working together with other specialist groups.

Ambu – a visionary and international workplace where your efforts matter
Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us, you will get the opportunity to work in an international head office with an informal working environment.

We offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.

Application and deadline
You can get more information about the job and about Ambu A/S by contacting Annette Bitz, Head of Biosafety , telephone no. +45 7225 2000 or by e-mail [email protected].

If you are interested in applying for the position, then please apply as soon as possible. This job ad might be online until 15th May 2020.

Your application will be treated with confidentiality

About Ambu
Since 1937, breakthrough ideas have fuelled our work on bringing efficient healthcare solutions to life. This is what we create within our fields of excellence – Anaesthesia, Patient Monitoring & Diagnostics, and Emergency Care. Millions of patients and healthcare professionals worldwide depend on the functionality and performance of our products. We are dedicated to improve patient safety and determined to advance single-use devices. The manifestations of our efforts range from early inventions like the Ambu Bag™ resuscitator and the legendary BlueSensor™ electrodes to our newest landmark solutions like the Ambu aScope™ – the world’s first single-use flexible endoscope. Our commitment to bringing new ideas and superior service to our customers has made Ambu one of the most recognized medical companies in the world. Headquartered near Copenhagen in Denmark, Ambu employs approximately 2,750 people in Europe, North America and the Asia Pacific. For more information, please visit www.Ambu.com