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Interested in this job?

Ooooh, exciting, right? Be our new Medical Device Risk Manager and help us make diabetes suck less.

Medical Device Risk Manager

Vienna Head Office
Regulatory / Legal

Full Time (Vienna)

 

Diabetes is a pesky monster — and that’s putting it mildly. If you’re serious about helping us face it head on, come join us!

Most of our customers live with insulin-dependent diabetes. Everyday life with diabetes is often tedious and exhausting – and that’s exactly what motivates our work at mySugr. Always driven by our motto to “make diabetes suck less,” we develop award-winning apps, integrate medical devices into our products, and work with health insurance companies and industry partners to make life with diabetes a bit better. For a behind-the-scenes look, check out our Monster Culture blog and this little video to see what makes mySugr tick. 

Here’s what we’re looking for:

As our dedicated Medical Device Risk Manager you will lead the overall Risk Management efforts at mySugr in accordance with ISO 14971. You will provide Risk Management expertise to the organisation for new products and throughout the product life cycle. With a passion for people and understanding their needs, you will work within cross functional teams providing guidance on the development and incorporation of Risk Management during all design phases of our products. We are looking for an energetic and outgoing person, passionate about minimising risk to the health of our patients. If this sounds like you, we’d love to talk to you about joining us on our mission.

Your upcoming mission:

  • Stay up to date on new regulations and standards that affect Risk Management for medical devices
  • Drive knowledge transfer on Risk Management related topics to the organization
  • Participate in regulatory inspections and Notified Body audits to represent the Risk Management process
  • You will ensure that the Risk Management procedures, processes and files are updated where required. Furthermore, this includes the responsibility to develop and maintain Risk Management Files for EU (class IIa and IIb devices)

Essential skills for your mission:

  • 5+ years of relevant experience
  • Good understanding of the medical device environment, preferably software as a medical device
  • Attended medical risk sessions for class 2 and higher
  • Profound knowledge of ISO 14971 and familiarity with associated standards (ICE 62304, IEC 62366, etc.)
  • Know the playground of medical devices in EU/USA
  • Experience working on overlapping projects with your keen project management and organisational skills
  • Ability to manage Risk Management aspects of projects including planning, deliverables and priorities for company compliance
  • Team spirit and love to work in an open, iterative and collaborative way
  • Confident speaking in front of others and moderating Risk Management sessions
  • Great written and verbal communication skills in English

Bonus Skills:

  • Formal education in relevant field
  • Technical understanding and love for innovative apps or software development
  • Medical background and/or knowledge of the diabetes industry or other comparable health industries
  • Great written and verbal communication skills in German

Here's what you can expect from us:

  • Ambitious and passionate people who building meaningful, global products
  • An innovative agile working environment allowing for collaboration with really smart people and knowledge sharing in cross-functional teams 
  • An energetic and vibrant workplace
  • A growing organization with room for development
  • A non-corporate environment, but the leverage of a global market leader (Roche family)
  • Loads of benefits (brand new Apple hardware, fitness, public transport, lunch benefit, language classes, professional training budget, chance to join global conferences...)
  • Flexible working hours and the opportunity for home office days, 5 weeks vacation
  • A kick-ass office with a rooftop terrace, fully stocked kitchen and amazing barista coffee machines in the middle of Vienna… oh, and did we mention the best team in the world!Additional social benefits (fitness, public transport, lunch benefit,..)

Here at mySugr we are committed to providing a healthy, equal and inclusive working environment for our Monster Tamers to help them make diabetes suck less! 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 at mySugr - both professionally and personally.

Interested? Great. For this position we offer an annual gross salary starting from EUR 45k plus a variable bonus. We are fully prepared to adjust our actual offer to your skill set, skill level and previous relevant experience.

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.

 

Interested in this job?

Ooooh, exciting, right? Be our new Medical Device Risk Manager and help us make diabetes suck less.