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Interested in this job?

Ooooh, exciting, right? Be our new Regulatory & Medical Device Risk Manager - Freelancer (m/f/d) and help us make diabetes suck less.

Regulatory & Medical Device Risk Manager - Freelancer (m/f/d)

Vienna Head Office
Regulatory / Legal

Full Time / Freelance (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!

Being a global leader in integrated Personalised Diabetes Management (iPDM), Roche Diabetes Care collaborates with pioneers around the globe, including people with diabetes, caregivers, healthcare providers and payers. We aim to transform and advance care provision and foster sustainable care structures. Under the brands RocheDiabetes, Accu-Chek and mySugr, comprising glucose monitoring, insulin delivery systems and digital solutions, we unite with our partners to create patient-centred value. By building and collaborating in an open ecosystem, connecting devices and digital solutions as well as contextualising relevant data points, we enable deeper insights and a better understanding of diabetes, leading to personalised and effective therapy adjustments. For a behind-the-scenes look, check out our Monster Culture blog, this little video and Roche code4life to see what makes mySugr and Roche tick.

Here’s what we’re looking for:

A Regulatory Affairs Expert with profound knowledge in Medical Device Risk Management to drive the overall Risk Management efforts at mySugr in accordance with ISO14971.You will ensure compliance with the Medical Device Risk Management process of mySugr and maintain Risk Management files for EU class IIb and IIa 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 Risk Manager you will ensure that you 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. We’d love to talk to you if you want to be part of our mission and our growing team.

Essential skills for your mission:

  • 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 very structured and detailed, with high ability 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 in working on overlapping projects - i.e. 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 way
  • Confident speaking in front of others and moderating risk management sessions
  • Great written and verbal communication skills in English
  • Willingness to working in cross functional, fast-paced corporations
  • Valid Austrian work permit

Bonus skills:

  • Bachelor's degree (or equivalent experience) and wide-ranging related experience in the area of Medical Device Risk Management or Master's degree with several years of related experience
  • 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
  • Experience working in startup environments

Here's what you can expect from us:

  • Ambitious and passionate people building meaningful products 
  • An innovative agile working environment allowing for collaboration with really smart people and knowledge sharing in cross-functional teams 
  • A growing organization with room for development
  • Not a corporate environment, but the leverage of a global market leader (Roche family)
  • Flexible working hours and home office policy
  • 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!

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

Make sure to read our Privacy Notice for Applicants.

Interested in this job?

Ooooh, exciting, right? Be our new Regulatory & Medical Device Risk Manager - Freelancer (m/f/d) and help us make diabetes suck less.

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