Principal SaMD Quality System Specialist
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Søborg
Are you ready to implement a world-class compliant and simple Quality Management System (QMS) that can support our continued growth of Software as Medical Device (SaMD) solutions? Would you like to ensure our SaMD solutions meet requirements for the benefit of our patients across the world? Then this is your chance to join us as Principal SaMD Quality System Specialist. Start your application for a life-changing career!
The position
You will be appointed Process Owner Delegate for the Novo Nordisk SaMD QMS and will be responsible for ensuring the QMS is compliant with relevant external requirements and, equally important, guaranteeing it is fit-for-purpose and simple to use. Your key tasks: Chair the Digital Health Focus Group and set direction for translation of regulations and standards applicable for the SaMD QMS Foster strong collaboration with a wide range of internal and external stakeholders to influence the standards, regulations, and their application Conduct training and education of NN stakeholders This is an exciting opportunity to contribute to the execution of the recently updated strategic priorities within Devices & Delivery Solutions (DDS) in relation to SaMD. Thus, you will strongly focus on adapting processes and how we work, playing a key role in driving new strategic- and improvement initiatives. We offer a unique learning chance and ample opportunities for personal development and interaction with diverse stakeholders across Novo Nordisk. You will report to the Vice President of Companion SaMD Solutions (CSS) and be a member of the CSS leadership team.
Qualifications Master’s Degree in natural sciences or engineering combined with experience in SaMD and/or Medical Device development + 10 years of demonstrated ability to drive the establishment of lean and fit-for-purpose processes in regulated environments which has enabled you to get a strong understanding of quality standards and regulatory requirements Prior SaMD QMS experience is a strong plus Strong focus on continuous improvements Proven experience with change management Excellent written and verbal communication skills in English and collaboration capabilities are vital for working with cross-functional teams About the Department
CSS is part of DDS organisation with a 400+ global team serving the entire Novo Nordisk pipeline of drugs. The CSS area has approx. 40 employees, located in Denmark (Søborg) and US (Seattle and Boston). The CSS organization consists of three departments and works end-to-end with SaMD from research to operations & maintenance. We are a global organisation with many different nationalities, so good intercultural collaboration skills are key.
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 To learn more about the position, please contact Charlotta Bennrup at [email protected] or mobile +4530758404. Deadline
4 August 2023. We will review the applications on an ongoing basis, so we encourage you to apply as soon as possible. To ensure a fair and efficient recruitment process, please refrain from adding a photo in your CV or 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.
The position
You will be appointed Process Owner Delegate for the Novo Nordisk SaMD QMS and will be responsible for ensuring the QMS is compliant with relevant external requirements and, equally important, guaranteeing it is fit-for-purpose and simple to use. Your key tasks:
Qualifications
CSS is part of DDS organisation with a 400+ global team serving the entire Novo Nordisk pipeline of drugs. The CSS area has approx. 40 employees, located in Denmark (Søborg) and US (Seattle and Boston). The CSS organization consists of three departments and works end-to-end with SaMD from research to operations & maintenance. We are a global organisation with many different nationalities, so good intercultural collaboration skills are key.
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 To learn more about the position, please contact Charlotta Bennrup at [email protected] or mobile +4530758404. Deadline
4 August 2023. We will review the applications on an ongoing basis, so we encourage you to apply as soon as possible. To ensure a fair and efficient recruitment process, please refrain from adding a photo in your CV or 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.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 23.6.2023, 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.
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