Device/Software as Medical Device Quality Specialist, Global Development
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Søborg
- Quality
- Søborg
Device/Software as Medical Device Quality Specialist, Global Development
Do you want to break new ground? Do you want to support bringing innovative digital solutions to our patients participating in our clinical trials worldwide? Do you want to use your experience and innovative skills in making sure that we live up to device regulatory requirements the most efficient way? R&D Quality are searching for a Device/Software as a Medical Device (SaMD) Quality specialist with Medical Device Design Control, Software and QA experience that can support Novo Nordisk in this exciting journey.
About the department
The R&D Quality area is part of Global Development placed in the R&D organisation. R&D Quality also have a dotted line to NN Quality and is responsible for quality assurance and compliance support for all clinical trials. R&D Quality is divided into three departments. The open position is in the Global Clinical Processes & IT department responsible for SOP deviations, GCP serious breaches, supplier assessments, digitalisation initiatives, Quality Assurance for device and SaMD trials and Quality Assurance for IT systems.
The position
We are expanding our great department to cover the need for more expertise in the evolving area of medical devices and SaMD solutions in the clinical area.
As Device/SaMD Quality Specialist you will ensure compliance for device and SaMD solutions for clinical trials and support the digital transformation. This include building a framework for how we ensure quality and compliance for these activities, review and approve key quality documents and participate in audits and inspections.
As Software as a Medical Device products are new to Novo Nordisk, you will also take part in collaborating, training, communicating, and knowledge-sharing with stakeholders across Novo Nordisk and participate in cross-organisational projects.
As this is new territory for us in R&D quality, you are expected to take part in the development of the area, be curious and proactive in identifying best practices, and drive change across the organisation.
You will ensure compliance with regulatory requirements and will continuously improve the quality mind-set within Novo Nordisk whilst ensuring we have competitive speed and flexibility to meet our business needs.
Qualifications and competencies
You hold a relevant scientific academic degree, e.g. within Computer Science, Engineering, Software Engineering or equivalent and are fluent in written and spoken English. You have a proven track record with 5-7 years’ experience in Medical Device Design Control and/or IT/software engineering. You have a strong knowledge of regulatory requirements related to Medical Devices e.g. MDR and relevant ISO standards and how they apply to software-based products - and/or IT/software engineering. You are familiar with maintaining a Quality Management System and certificates.
You have knowledge and great interest within digitalisation, new technologies and work methods.
You have worked with an innovation agenda and have a ‘can do’ mind-set, which is required to explore new ideas and ways of working. You are known for your ability to set direction, suggest compliant solutions supporting business needs, your structured approach and your ability to spot opportunities. Your excellent communication and stakeholder management skills enables you to liaise at all levels of the organisation, in different geographies and from diverse cultures. The job requires strong strategic focus, high degree of independence and great leadership competencies.
You are a team player, have strong interpersonal skills, you are highly engaged, robust in meeting challenges and willing to take responsibility. You are courageous, innovative, strive for simplicity and demonstrate a risk-based, solution-oriented approach.
Contact
For further information, please contact Charlotte Manniche (CMCX) at +45 3075 3761.
Deadline
22-Nov-2020
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 17.11.2020, 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.
- Produktspecialist
- Søborg
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