Safety Risk Management Engineer in Clinical Trials

Are you ready to play a key role in Novo Nordisk’s medical device development within clinical trials and help improve the life of our patients? In this position you will get a unique opportunity to use your educational and professional background to bring drugs in medical devices into clinical trials in collaboration with many stakeholders across the Novo Nordisk organization.
Apply now for a life-changing career! The position
We are looking into a significant increase in the number of clinical trials in the Novo Nordisk pipeline and therefore we need a new Safety Risk Management Engineer to support getting our devices ready/approved for the participants in our clinical trials. As a Safety Risk Management Engineer, you will take part in many different clinical trials where devices are needed for drugs to go out to our trials.
You thrive with working on many trial tasks simultaneously and navigating both in many tasks but also collecting input from many stakeholders. You will be interacting with stakeholders across the organization such as regulatory affairs, drug development, system engineering, user communication, clinical supply etc. to drive the safety risk management activities.
Your main tasks will include:
• Safety risk analysis and documentation of the safety risk management process within clinical trials with durable devices. This is to ensure the medical device is safe to use by participants in trials.
• Maintain technical documentation for devices, to ensure compliance against regulatory requirements.
• Planning and coordination of safety risk management deliverables, to ensure overall project timelines are met.
• Preparation of documents for submission with health authorities and supporting the subsequent regulatory interactions.
• Involvement in various improvement projects to further develop the safety risk management process within clinical trials.
• Working with a large range of internal and external stakeholders where you will play an important role in aligning these stakeholders across professional areas of expertise. Qualifications
You will be a great asset to our team because you have:
• BSc or master’s degree or equivalent within engineering or natural science.
• +1 year of experience from working with either medical devices (and/or combination products), or risk management in other regulated industries.
• Analytical and structured skills.
• Professional proficiency within oral and written English is essential.
As a person you are collaborative and use your great interpersonal skills to communicate openly, reach out to stakeholders across the organization, and facilitate meetings and workshops to reach decisions and ensure progress. You are a strong team player recognised for your interpersonal skills. You bring a "can do" spirit, a healthy common sense, and a good sense of humour to your work. About the department
In the Risk Management department, we are approximately 20 highly skilled professionals and specialists divided into two teams, that have Safety Risk Management as the common denominator. Safety Risk Management underpins many aspects of medical device development, so our work is integrated into various processes within the development and manufacturing landscape, and our stakeholders have backgrounds in a variety of engineering and scientific disciplines.
We are part of the Novo Nordisk Devices and Delivery Solutions unit, which is the organization responsible for the development of device solutions for medical self-treatment within all business areas of Novo Nordisk. In our department we have a wide range of development projects in different phases that we contribute to – from connected devices to purely mechanical pen- and auto-injectors. Our main aspiration is to further advance our offerings to people living with chronic diseases and their healthcare professionals through new technologies.
You will join a dynamic, international, and innovative environment, where highly skilled professionals work closely together to develop next generation medical devices. Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Cathrine Berg Larsen on [email protected] or mobile phone +45 30794289. Deadline
6 September 2023.
We are screening candidates and conduct interviews on an ongoing basis.
To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.