SaMD Senior QA Advisor
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Søborg
Do you want to break new ground? Do you want to deliver innovative digital solutions to 29.000.000 patients worldwide? Digital Health develops digital therapeutics and solutions for people living with Diabetes and other chronic diseases. We are searching for a Software as a Medical Device (SaMD) Senior QA Advisor with Medical Device Design Control, Software and QA experience that can support Novo Nordisk in this journey.
The position Software as a Medical Device Senior QA Advisor you will ensure compliance for Digital Health solutions throughout their life-cycle from development through operations to retirement. Digital Health solutions include Software as a Medical Device and Health Software solutions owned by Novo Nordisk or acquired as a Service. • Responsible for reviewing and approving key quality documents, releasing Digital Health products to the market and participating in audits and inspections.
• Taking part in collaborating, training, communicating, and knowledge-sharing with organization across Novo Nordisk.
• Participating in cross-organisational projects e.g. ensuring compliance while working Agile.
• 10 days of travel per year might be expected. Qualifications • A Master's degree within relevant field
• Ideally 5-7 years of experience in Medical Device Design Control and/or IT/software engineering.
• A strong knowledge of regulatory requirements related to Medical Devices and how they apply to software-based products - and/or IT/software engineering
• Familiarity with maintaining a Quality Management System and certificates.
• Experience with an innovation agenda and have a ‘can do’ mind-set.
• Ability to set direction, to suggest compliant solutions supporting business needs.
• Fluency in English (oral and written) is a prerequisite.
About the department Digital Health & Staffs Quality is responsible for quality assurance in Novo Nordisk’s Staff Areas incl. Digital Health. Digital Health products are a prioritized strategic focus area for Novo Nordisk. We are a team of 11 employees with high management focus and responsible for an area new to the industry, regulators, and Novo Nordisk why we need to provide new ideas, competencies, solutions, and perspectives in order to succeed on our journey.
Working at Novo Nordisk At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
Deadline
26th January 2023 Contact
For further information, please contact Director, Tine Andersen at [email protected] or +4530757671 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 Software as a Medical Device Senior QA Advisor you will ensure compliance for Digital Health solutions throughout their life-cycle from development through operations to retirement. Digital Health solutions include Software as a Medical Device and Health Software solutions owned by Novo Nordisk or acquired as a Service. • Responsible for reviewing and approving key quality documents, releasing Digital Health products to the market and participating in audits and inspections.
• Taking part in collaborating, training, communicating, and knowledge-sharing with organization across Novo Nordisk.
• Participating in cross-organisational projects e.g. ensuring compliance while working Agile.
• 10 days of travel per year might be expected. Qualifications • A Master's degree within relevant field
• Ideally 5-7 years of experience in Medical Device Design Control and/or IT/software engineering.
• A strong knowledge of regulatory requirements related to Medical Devices and how they apply to software-based products - and/or IT/software engineering
• Familiarity with maintaining a Quality Management System and certificates.
• Experience with an innovation agenda and have a ‘can do’ mind-set.
• Ability to set direction, to suggest compliant solutions supporting business needs.
• Fluency in English (oral and written) is a prerequisite.
About the department Digital Health & Staffs Quality is responsible for quality assurance in Novo Nordisk’s Staff Areas incl. Digital Health. Digital Health products are a prioritized strategic focus area for Novo Nordisk. We are a team of 11 employees with high management focus and responsible for an area new to the industry, regulators, and Novo Nordisk why we need to provide new ideas, competencies, solutions, and perspectives in order to succeed on our journey.
Working at Novo Nordisk At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
Deadline
26th January 2023 Contact
For further information, please contact Director, Tine Andersen at [email protected] or +4530757671 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 5.1.2023, 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
- Søborg
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