Part Time/Full Time (Vienna) -
Diabetes is a pesky monster and that’s putting it mildly. However, 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 we work on at mySugr. True to the motto "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 see what makes mySugr tick.
Here’s what we’re looking for:
A Junior 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; the Junior Regulatory Manager will work closely with product development to shape our future products.
- 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 oral and written English
- Enjoy learning new things
Nice to haves:
- Knowledge of the diabetes industry or other comparable health industries
- Experience with audits by notified bodies and/or FDA
- Experience working in startup environments
Here’s what to expect:
- 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)
- 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 days, 5 weeks vacation
- A kick-ass new 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 a competitive annual gross salary of minimum EUR 40k plus a variable bonus. 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.