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:
A Regulatory Manager with experience in medical device regulation. 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 1 and 2(b) products on the market and is ISO 13485 certified; as a Regulatory Manager will work closely with product development to shape our future products.
Essential skills for your mission:
- Knowledge of the current EU and FDA medical device regulations and guidelines
- Knowledge of the ISO standards for quality, risk, usability and lifecycle management
- Experience in authoring lean process descriptions that align with business importance and formal necessities
- 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
- Minimum of 2 years experience in the area of Medical Device and/or Regulatory Affairs
- Excellent written and verbal communication skills in English
- Enjoy learning new things
- Knowledge of the diabetes industry or other comparable health industries
- Experience with audits by notified bodies and/or FDA
- 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 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!
Interested? Great. For this position we offer an annual gross salary starting from EUR 44k 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.