Experienced Safety Risk Manager for Digital Health projects
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Søborg
- Engineering
- Søborg
Experienced Safety Risk Manager for Digital Health projects
Novo Nordisk A/S, a global healthcare company with 90 years of innovation and leadership in diabetes care, is looking for an experienced safety risk manager with medico and software background who can strengthen capabilities in a newly established department, developing a new product category of digital health solutions.
About the area
Device Research & Development is an area within Global R&D, responsible for the development of medical devices for self-treatment within all therapy areas of Novo Nordisk A/S. We invented the market for insulin injection devices with the launch of the world’s first insulin pen in 1985 and aim to further advance our offerings to people living with diabetes and their healthcare professionals through Digital Health solutions. Our projects are pioneering a journey where new technology meets real user needs for the benefit of people living with diabetes.
About the department
You will join a newly established department driving Software as a Medical Device (SaMD) design controls in the Digital Health projects. This includes systems engineering, requirement management, safety risk management and usability engineering. The department is co-located with the Digital Health Corporate IT Project Management and Commercial Innovation area in the Novo Nordisk A/S facilities in Søborg.
The Job
You will be a member of one of the project teams developing applications to support the Novo Nordisk digital Health aspiration. The teams comprise software architects, system engineers, project managers, IT system owners, external development partners, commercial leads, usability engineers and designers - and you are a central and integrated member of the team. Together we are on an exciting journey that includes several product launches in the coming years.
Your role as a risk manager is to prepare the overall risk management plan, conduct the system risk analysis for the product, align the risk management approach towards external development partners, identify and implement risk control measures in the system requirements and prepare the risk management report for the product. You are also responsible for relevant risk management related design documentation for submission, all of which is necessary to bring the new category of products to the market.
Qualifications
You hold an academic degree within Engineering (Medico, Mechanical, Hardware or Software) and have several years of experience as a risk manager within the field of Medical Device Development - preferably SaMD products. You have experience in collaborating with external development partners and with medical device regulation and standards like ISO 14971, IEC 62304, IEC 82304 and ISO 13485. Knowledge of cyber security and the impact on safety risk management is a plus.
You are able to analyse and understand complex structures and systems and communicate them in a comprehensible way. You can work thoroughly and dedicated on risk management analyses while also engaging with internal and external stakeholders to align on the risk management approach and processes. You are self-motivated, ambitious and result-oriented and have knowledge of, or experience with, software development principles and tools (e.g. agile development, Scrum, Jira, Jama etc.). Proficiency in oral and written English is essential.
At Device Research & Development we use our skills, dedication and ambition to help people with chronic diseases. You will get the opportunity to take part in this, and in addition enhance your career, benefiting from the possibilities for professional and personal development provided by Novo Nordisk A/S.
Contact
For further information, please contact Anders Brinck Madsen +45 30 75 46 16.
Deadline
August 5, 2019.
Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified.
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 chronical 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 "Finansmedarbejder", og befinder sig i kategorien "Økonomi og jura".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 19.6.2019, 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.
- Finansmedarbejder
- Søborg
- Mandag den 05. august 2019
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