Title QA/RA SPECIALIST
Job Category Research & Development
Job Description PURPOSE:
Device R&D (DRD) has established a device research organisation in Seattle, US Device Research (USDR), with the purpose to explore and develop technology and medical devices with the potential to add value to patients and Novo Nordisk future business within therapeutic areas covered by Novo Nordisk corporate strategy.
The QA/RA SPECIALIST is responsible for 1) being up to date on relevant rules and regulations from e.g. FDA and EMA on software as medical device (SaMD), and to ensure that it is being applied in the development of SaMD according to FDA 21 CFR 820.30 and relevant EU regulation; and 2) to ensure that development of SaMD at USDR is carried out under design control in accordance to and compliance with the relevant quality management system (QMS). SaMD projects will potentially be developed all the way to launch at USDR.
The QA/RA SPECIALIST is contributing to the DRD ambition to ensure sustainable Device Leadership for Novo Nordisk by ensuring quality and regulatory compliance when developing new SaMD projects all the way to launch readiness at USDR.
The QA/RA SPECIALIST reports to the VP of USDR.
Further, the QA/RA SPECIALIST will have a dotted reporting line to the VP of Device QA in DRD in Denmark to ensure a close collaboration with the QA organisation in headquarters. Independent QA reviews will most likely have to be performed by QA professionals from the Danish organisation.
The QA/RA SPECIALIST will be part of the project core team as defined in the relevant project manual.
The QA/RA SPECIALIST will work closely with the digital device project team, including system engineer, risk manager, etc. as well as relevant external partners to ensure documentation is developed to a satisfactory quality level.
Developing a digital medical device from proof of concept to launch under design control according to FDA 21 CFR 820.30 and relevant EU regulation requires a continuous interaction with stakeholders to ensure continued support and quality compliant deliverables fulfilling a plurality of requirements, including regulatory, commercial, technical, etc.
Device QA: professionals and VP
NN Regulatory affairs: RA professionals, managers, VP
Device R&D: SPMs, VPs and specialists
NN Digital Health Marketing: professionals and VP
Corp IT: project managers, VP
Development of SaMD in Novo Nordisk is expected to be conducted in close collaboration with external medical software development partners, so a large part of the job is to manage specifications, deliverables and relationship with an external development partner working under design control.
Development partners, e.g. Flex
Relevant authorities, e.g. FDA, EMA, etc.
The work is planned and carried out independently based on targets agreed upon by USDRman, Device R&D management, Corp IT, and Digital Health Marketing, and in close collaboration and alignment with the Danish Device QA organisation.
Quality and compliance:
Ensure all relevant requirements are considered for delivering a coherent and compliant documentation package (Design History File) adequate for FDA/EMA submission of SaMD. Documentation will need to be aligned with both the relevant NN QMS and the QMS of the development partner.
It is a key focus area for the QA/RA SPECIALIST to ensure that USDR is in compliance with requirements defined in relevant QMS.
Ensure existing and new relevant regulation and QMS requirements are identified and adequately applied.
Identify and manage relations with external collaboration partners.
Take adequate measures including define training requirements to ensure that USDR project members are qualified and operating in compliance with requirements defined in QMS.
Level of complexity:
Responsible for ensuring alignment with latest regulatory requirements when working under design control, as well as working according to procedures as defined in Novo Nordisk QMS.
Ensure key regulatory deliverables are provided as required in relevant regulation including risk management, human factors engineering, system engineering, verification and validation, etc.
Ensure key quality processes required by relevant QMS are performed in compliance with relevant SOPs, including change control, CAPA, non-conformities, etc.
The job is based in Seattle, US.
Approximately 20% overnight travel to development partners and HQ in Denmark.
KEY SUCCESS FACTORS:
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Education Level: B.Sc. required, M.Sc. preferred.
Experience Level: Advanced degree may be substituted for experience as appropriate. Minimum 1 year of relevant experience if PhD, 3 years if M.Sc. and 5+ if B.Sc. Minimum 3 years of experience with QA and regulatory requirements in medical device development.
Specific or technical job skills: Quality assurance of medical device development, experience in interacting with FDA or similar, experience with technical writing or medical writing, software development. Previous experience with software development for medical usage regulated under 21 cfr 820.30 and/or EU regulation is preferred.
Oral and written English skills on negotiation level. Experience with stakeholder management. Experience with presentations and professional communication.
As a person, the QA/RA SPECIALIST is expected to be:
strong in written communication and documentation,
well-structured working approach,
a good communicator who is able to inspire and motivate others,
good at team work,
able to find constructive solutions to narrowly defined problems,
able to work fast and under pressure as needed when replying to authority requests.
Department NNRC - US DEVICE RESEARCH MGMT
Position Location US - Seattle, WA
State/Provinces US - WA
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle helping us find the right balance between compassion and competitiveness
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• Post ID: 46758838 seattle