Teamleader User Communication Development

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Hillerød

Are you passionate about medical device labelling and Instructions for Use? Do you have a strong track record of leadership and get energized by people and compliance? Do not hesitate to apply for this exciting opportunity. The position We are seeking a highly motivated Team Leader for our Medical Device Labelling team. The successful candidate will be responsible for overseeing the development process, and Life Cycle Management of our Instructions for Use, on all media. The main responsibilities will be to:
  • Manage a team of labelling specialists, providing leadership, guidance, and support to ensure high-quality output and an engaging and sustainable work environment
  • to ensure timely and high-quality delivery of IFUs for our medical devices and combination products
  • ensure the development and the implementation of processes and standards for IFU development to ensure consistency and compliance with regulatory requirements and new business areas.
  • manage and oversee the labelling process for medical devices, ensuring compliance with relevant regulations and standards (e.g. FDA, EU MDR, ISO)
    • Moreover, you will collaborate with cross-functional teams, including Regulatory Affairs, Quality Assurance, Local Affiliates, Systems Engineering, Risk Management. As a Team Leader, you will ensure the team’s up-to-date knowledge of labelling regulations and standards, provide guidance and feedbacks, and ensure compliance with any changes or update. Besides that, you and your team will be keeping up-to-date with industry regulations, guidelines, and trends related to IFU development and incorporate best practices into processes and standards Qualifications To succeed in this position, you have:
  • Minimum a bachelor’s degree in a relevant field (e.g. engineering, biology, chemistry, pharmacy)
  • At least 5 years of experience in medical device labelling or a related field
  • Experience of managing a team of labelling developers
  • Knowledge of relevant regulations and standards (e.g. FDA, EU MDR, ISO 13485, 14971)
    • Preferably, you have managed a team of labelling developers before. You posess excellent communication and leadership skills to enable a great working environment, strong attention to detail and ability to manage multiple tasks and projects simultaneously. About the department User Communication Development and LCM consist of 10 motivated colleagues. The team takes responsibility of our IFU concepts after concept choice and brings them through development and life cycle management by ensuring input from risk management, regulations, and market feedback. The team works with printed IFU’s, eIFU’s, IFU for SAMD and for our clinical trials. 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. We offer a modern and flexible working environment, giving everyone the opportunity to be themselves and do their best whilst working with some truly talented colleagues. We also cater for the little things that matter with (amongst many perks) a continuous supply of great coffee and refreshments, healthy fruit snacks, seriously good lunches, fitness centres and abundant opportunities to learn, progress and be inspired. Contact Rasmus Klinck, Director, Secondary Packaging Development and Technical Writing +4530798754 Deadline May 10th 2023. 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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    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 21.4.2023, men kan have været deaktiveret og genaktiveret igen.

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