Senior Medical Device and Combination Product Expert

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Hillerød

Are you looking to bring your quality expertise to the next level by being responsible for Medical Devices and Combination Products? Are you eager to specify the quality level for New Product introduction and ready to play a key role in introducing new life-changing products in new countries? Then apply today and join our Device Quality Frame Specification and Methods within Device Manufacturing Development (DMD). The position As Senior Medical Device and Combination Product Expert, you will work with a broad stakeholder landscape and in different projects to develop Control strategies within Manufacturing, Release and Submission of medical devices and Combination product testing. You will be involved every time a new Site or a new Contract Manufacturing Organisation (CMO) will be implemented globally. Most of the CMO’s are in Europe and USA. As Senior Medical Device and Combination Product Expert you will be part of a highly engaged and dedicated professional team, and your responsibility will be to own, develop and optimize Device Quality Frame Specifications (QFS) and associated documents, for example submission. These specifications determine if the Drug Device Combination products (DDC) have the required quality to be released for next process in the value chain and are vital to ensure that Novo Nordisk delivers a quality product to patients all over the world. The purpose of a QFS is to translate related design inputs, design outputs and safety risk management outputs into a specification to ensure quality and safety requirements needed to release an injectable finished product. Some of your focus include:
  • Working with regulations, risk documentation and quality control to set up requirements and parameters for testing during production and in Quality Control (QC)
  • Becoming an expert of the submission process for new countries or new product introduction
  • Being part of cross functional project groups responsible for implementation and improving quality level of new combination products and acquisition products
  • Provide global production/QC support and take part in driving improvement projects on own internal processes
    • There will be opportunities for travel activities in small scale (1-2 times a year). Qualifications To be considered for this position, we imagine you have:
  • A master’s degree within relevant Engineering disciplines, biotechnology Pharmacy, veterinarian or equivalent
  • A previous experience within quality assurance or regulatory affairs
  • Familiarity with assembly processes and working with suppliers in a global environment
  • Fluency in English, both written and spoken
    • It would be considered as an advantage if you have knowledge of ISO13485, Current Good Manufacturing Practice (cGMP), validation and/or Lean. Please don’t hesitate to apply even if you don’t match all the requirements mentioned above: we welcome applicants from other field too, as long as you share our passion for quality, GMP and problem solving, and are keen to acquire professional competencies to become what we describe as an “ideal candidate”. On a personal level you make a difference and through your commitment and perseverance, you complete your tasks in close cooperation with your colleagues. You are collaborative and enjoy sharing knowledge and experiences with stakeholders. You’re independent and not afraid to take the initiative and make decisions. About the department You will be part of Device Manufacturing Development, Product Control & Global Support, where we support device development from the early R&D development stages into production for clinical trials and finally into production to market. We are a team with employees that are both Danish and international, coming from various educational, as well as cultural backgrounds. We complement one another’s knowledge and skills, always seeking to help, support and spar when someone needs it. At work we try to keep a light and informal tone, so if you can bring a dose of healthy sense of humour along, then you will fit right into the team. 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, please contact Charlotte Hunding, Senior Manager Device Quality Frame Specification and Methods, at +45-30799197. Deadline 18 December 2023. Please note that applications will be reviewed and interviews will be scheduled on an ongoing basis. Therefore, we encourage 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. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your resume. 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.


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    Arbejdsstedet er beliggende i Hillerød.

    Jobbet er oprettet på vores service den 22.11.2023, men kan have været deaktiveret og genaktiveret igen.

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