Senior Biosafety Specialist
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Ballerup
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 Senior 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 become part of a dynamic innovation culture characterized by teamspirit. We have a tradition for fast completion of projects, which means that there is a visible link between your results and Ambu’s growth. Our Global Innovation team consists of 120 people, located at our headquarters in Ballerup. We focus on developing new products and processes that combine technologies in new and innovative ways.
As Biosafety Specialist you will be a part of the Global Biosafety team consisting of 4 colleagues in Denmark and 4 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 biological and chemical characterisation testing
• Prepare biological evaluation reports, toxicological risk assessments, biological equivalence, FDA 510K submissions and material interaction 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 10-15 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 min. 5 years of relevant experience from a medical device or pharmaceutical company and experience with biological evaluations, toxicological assessments, chemical testing, REACH regulation, FDA 510K submissions 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.
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 20801620 or by e-mail [email protected].
If you are interested in applying for the position, then please apply as soon as possible as we interview continuously. This job ad might be online until 19th May 2021.
Your application will be treated with confidentiality
Ambu is looking for a Senior 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 become part of a dynamic innovation culture characterized by teamspirit. We have a tradition for fast completion of projects, which means that there is a visible link between your results and Ambu’s growth. Our Global Innovation team consists of 120 people, located at our headquarters in Ballerup. We focus on developing new products and processes that combine technologies in new and innovative ways.
As Biosafety Specialist you will be a part of the Global Biosafety team consisting of 4 colleagues in Denmark and 4 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 biological and chemical characterisation testing
• Prepare biological evaluation reports, toxicological risk assessments, biological equivalence, FDA 510K submissions and material interaction 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 10-15 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 min. 5 years of relevant experience from a medical device or pharmaceutical company and experience with biological evaluations, toxicological assessments, chemical testing, REACH regulation, FDA 510K submissions 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.
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 20801620 or by e-mail [email protected].
If you are interested in applying for the position, then please apply as soon as possible as we interview continuously. This job ad might be online until 19th May 2021.
Your application will be treated with confidentiality
Information og data
Denne ledige stilling har jobtypen "Biolog", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 21.4.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Biolog
- Ballerup
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