Advanced Safety Risk Manager, Medical Device Development

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Hillerød

Are you ready to make a significant impact on [xxxxx]'s medical device development projects and contribute to enhancing the lives of our patients? This role offers a unique opportunity for you to leverage your educational and professional expertise. You'll be at the forefront, guiding medical devices from development to the market, overcoming diverse challenges in collaboration with stakeholders across the entire [xxxxx] organization. Join us in this dynamic journey of innovation and transformation! The Position As a Safety Risk Manager colleague, you will play a central role in the development of our medical devices and drug-device constituent products and you will take part in one or more development projects spanning from early phase to submission and production. You will be interacting with many stakeholders across the organization, such as regulatory affairs, systems engineering, mechanical engineering, medical and science, and usability engineering, to drive safety risk management activities. Your main tasks will be focused on:

Participating in cross-functional development projects, either in one of our existing pen-injector platforms or new device platforms

Conducting safety risk analyses and documenting the safety risk management process to ensure the medical device's safety for patients and users, meeting regulatory approval standards

Collaborating with a broad range of internal and external stakeholders, playing a crucial role in aligning these stakeholders across professional areas of expertise

Planning and coordinating safety risk management deliverables to ensure overall project timelines are met

Preparing documents for submission to health authorities and providing support during subsequent regulatory interactions

Involvement in various improvement projects to further develop the safety risk management domain

Qualifications To thrive and succeed, we expect you to have:

A master’s degree or equivalent in engineering or natural science

Preferably, experience in the development of medical devices (and/or combination products) or risk management in other regulated industries

Excel analysis, workshops, stakeholder management, alignment in Risk area

Professional proficiency in both 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 analytical, and structured and thrive on being detail-oriented while also being able to see the bigger picture. You are a strong team player recognized for your interpersonal skills. You bring a "can do" spirit, a healthy common sense, and are looking for being part of and contributing to a great team culture. About the Department In the Risk Management department, we are approximately 26 highly skilled and curious 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 [xxxxx] Devices & Delivery Solutions unit, which is the organization responsible for the development of device solutions for medical self-treatment within all business areas of [xxxxx]. 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. Our department has a focus on being the best at what we do, but making sure that we have fun during the process. You will join a dynamic, international, and innovative environment, where highly skilled professionals work closely together to develop next-generation medical devices. Get to know us better - meet us at [xxxxx] Hillerød Working at [xxxxx] At [xxxxx], 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, to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Josephine Holm Sparlund at +[xxxxx]. Deadline 23 March 2025. To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] 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.

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Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Hillerød.

Jobbet er oprettet på vores service den 4.3.2025, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.

Type: Øvrige
Sted: Hillerød

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