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Interested in this job?

Ooooh, exciting, right? Be our new Senior Regulatory Manager (m/f/d) and help us make diabetes suck less.

Senior Regulatory Manager (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:

We are looking for a Senior Regulatory Manager with profound experience in the area of Medical Device regulations and in particular in Medical Device Risk Management (ISO14971). Our software apps are updated every other week thereby requiring lean and effective regulatory processes. As we are often pioneers in our field, we need a pragmatic person who is eager to expand into new fields of products and services. mySugr currently has class IIa and IIb products on the market and is ISO13485 certified; as a Senior Regulatory Manager you will ensure that the Risk Management procedures, processes and files are updated.

Essential skills for your mission:

  • More than 3 years professional experience with current EU and FDA Medical Device regulations and guidelines 
  • Ability to manage Risk Management aspects of projects including planning, deliverables and priorities
  • Professional experience with ISO standards for Quality, Risk Management, Usability Engineering and Software development
  • Professional experience with class IIa, IIb and/or 510k Medical Device registrations
  • Experience in audits by notified bodies 
  • Experience in working on overlapping projects - i.e. good at juggling multiple projects, multitasking and organizing yourself
  • Experience in optimising existing processes to work for multiple regulatory jurisdictions and at the same time minimising impact on daily work as far as possible
  • Excellent written and verbal communication skills in English
  • Enjoy learning new things
  • Willingness to working in cross functional, fast-paced corporations

Bonus skills:

  • Knowledge of the diabetes industry or other comparable health industries
  • Technical understanding and love for innovative apps or software development
  • Experience working in agile environments

What to expect:

  • Ambitious and passionate people building meaningful products for a global audience
  • 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)
  • 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 home office policy, 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!

Here at mySugr and Roche Diabetes Care we are committed to providing a healthy, equal and inclusive working environment for our Monster Tamers to help them make diabetes suck less and 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. 

Interested? Great. For this position we offer an annual gross salary starting from EUR 60k plus a variable bonus. If you are interested in a freelance position, please let us know! 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.

Make sure to read our Privacy Notice for Applicants.

Interested in this job?

Ooooh, exciting, right? Be our new Senior Regulatory Manager (m/f/d) and help us make diabetes suck less.

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