Product Responsible

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Hillerød

Are you excited about utilizing your device design control skills and collaborating with highly skilled professionals? Do you aspire to have complete ownership of your portfolio and play a crucial role in driving scalability, all while engaging with stakeholders at all levels? If so, then join us in Device Manufacturing Development (DMD) Device Development and take responsibility for some of our largest products. Don’t miss out, apply now! The Position As Product Responsible for our medical devices and combination products, you lead the post-launch phase of our product pipeline, overseeing device documentation, including delivery system platforms and design control documentation. You ensure a balance between regulatory and internal requirements while collaborating with various stakeholders for effective problem-solving. Some of your key tasks include:
  • Leading and driving existing device documentation activities, covering areas like mechanical design, requirements engineering, design verification, and safety risk management
  • Collaborating closely with Regulatory Affairs to ensure ongoing compliance and the update of device documentation
  • Maintaining a comprehensive understanding of technical documentation and delivering high-quality work
  • Contributing to continuous improvement in our daily activities and support process improvement initiatives
  • Qualifications To be successful in this role, we imagine you:
  • Hold a master’s degree in engineering, biomechanics, science, manufacturing, pharmaceutical, or a related field
  • Bring a minimum of 5 years of relevant experience in drug devices/combination products within regulatory affairs, project, or portfolio management roles in the medical device or pharmaceutical industry
  • Demonstrate strong networking and stakeholder management skills to provide direction, drive performance, and ensure quality, speed, and agility in a complex environment
  • Have knowledge of design control regulations, such as 21 CFR Part 820 and 21 CFR Part 4
  • Showcase proficiency in both spoken and written English
  • On a personal level, you possess excellent communication skills and can effectively handle complex problems that require structured problem analysis, you have experience in collaborating with stakeholders and are skilled in reaching consensus, even when opinions differ, you enjoy sharing knowledge with others and have a positive attitude towards work, including when under pressure, adaptable to changing priorities, set direction, and drive performance, ensuring quality and speed through a pragmatic and open-minded approach. About the department Device Development is part of Novo Nordisk DMD department, which is responsible for the design of medical devices and delivery systems, serving as the link between Device R&D and production. In Device Development, the main task is to maintain marketed products as well as develop new variants of existing product platforms. Our deliverables have direct impact on our ability to deliver to the market, on patient safety, and on compliance with the requirements of the authorities. As a member of the FlexTouch Development Team, you will collaborate with highly skilled colleagues and professionals who encourage knowledge sharing. You can look forward to an exciting role that involves plenty of interaction with various stakeholders at both global and local levels. Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. Contact For further information about the position, please contact Malene Fugl Andersen at +45-30758982. Deadline 17 December 2023. Please note that applications will be reviewed, and interviews will be conducted on an ongoing basis, therefore we advise you to apply as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. 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 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.


    Information og data

    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 1.12.2023, 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.
    • Øvrige
    • Hillerød

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