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The mySugr GmbH (https://www.mysugr.com/en/about-us) was acquired by Roche in 2017 and our Vienna office is one of Roches global sites. You will be located here, in the heart of Vienna, no matter if you work on a mySugr®, Accu‑Chek®, navify® or any other Roche product or solution. You can read more about the history of mySugr & Roche here (https://www.mysugr.com/en/about-us).

Here’s what were looking for:

We are looking for an expert with profound knowledge in Medical Device Risk Management to support the overall Risk Management efforts at Roche in accordance with ISO14971. You will ensure compliance with the Medical Device Risk Management process and maintain Risk Files for EU class IIa and IIb medical devices.

In this role you will work with cross functional product development teams to apply Risk Management during all design phases for new products and/or product updates. As a Product Risk Manager you will stay up to date on new regulations and standards that affect Risk Management for medical devices and also drive knowledge transfer on Risk Management related topics to the organization.

Essential skills for your mission:

• Minimum Bachelors degree (or equivalent) in a related field
• Minimum 3 years of professional experience in the area of Medical Device Risk Management (class II/class III) in the EU and/or US
• Ability to work in a very structured and detailed manner, with an aptitude to spot inconsistencies
• Ability to manage Risk Management aspects of projects including planning, deliverables and priorities
• Profound knowledge of ISO 14971 and familiarity with associated standards (IEC 62304, IEC 62366, etc)
• Experience working on overlapping projects – good at juggling multiple projects, multitasking and organizing yourself
• Passion for interacting with people and understanding their needs
• Energetic and outgoing personality
• Team spirit and love to work in an open, iterative and collaborative wayli>
• Confident speaking in front of others and moderating risk management sessions
• Great written and verbal communication skills in English
• Willingness to work in cross functional, fast-paced corporations

Bonus skills:

• Technical understanding and love for innovative apps or software development
• Medical background would be an asset
• Knowledge of the diabetes industry or other comparable health industries

In Austria, we have a legal obligation to disclose the minimum salary according to our collective agreement, which is gross EUR 3.843 per month for this position. But! Rest assured, we offer amazing competitive compensation packages which take into consideration current market trends, therefore you can expect a higher offer that reflects your experience level.

Who we are and what we care about?

We are committed to providing a healthy, equal and inclusive working environment for our employees to bring true relief to the patient! We care about family friendly career paths, sustainability, a healthy lifestyle and the flexibility of a modern workplace. We maintain a culture of learning and sharing, as well as open and candid feedback. At every level, there are many opportunities to develop and grow – both professionally and personally.

As a healthcare pioneer committed to transforming the lives of billions of people around the globe, we push boundaries to redefine what is possible. We know that early, accurate diagnosis is essential to maintain health, prevent disease and help advance new, targeted treatments and potential cures for the world’s most serious health problems. We have a passion for innovation and a profound commitment to make a lasting impact on society by continuing to improve the standard of care for humankind. Our culture inspires us to create healthcare that is sustainable, efficient and financially viable. Healthcare that is built on people’s needs, strong data and clinical insights. Healthcare that saves lives.

Interested?

Great. We’d like to hear from you! Just click that “Apply Now” button and send us your CV in English … and anything else that you think might impress us.

Roche is an Equal Opportunity Employer.