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FH Technikum Wien

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Senior Regulatory Manager (m/f)

Branche: Andere Berufe
Anstellungsart: Vollzeit
Dienstort: Schottenfeldgasse 69/3.1, A-1070 Vienna
monatl. Mindestgehalt (brutto): € 2.857,00
Beginn der Anstellung: ab sofort

Stellenbeschreibung

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. The 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. Learn more through our recent TV commercial.

Here's what we’re looking for

A Senior Regulatory Manager with experience in software products such as medical devices. Our products 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 Regulatory Manager will work closely with product development to plan and shape our future products.

Requirements

  • Professional experience with current EU and FDA medical device regulations and guidelines
  • Professional experience with ISO standards for quality, risk, usability and lifecycle management
  • Professional experience with class 2a, 2b and/or 510k device registrations
  • Experience in audits by notified bodies and/or FDA
  • 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
  • Excellent oral and written English
  • You like to learn new things

Nice to haves

  • Knowledge of the diabetes industry or other comparable health industries
  • Experience working in startup environments
  • Experience with other jurisdictions such as Canada, Japan, South Korea, Brazil etc.

What to expect

  • Passionate people building meaningful, global products
  • A candid environment where people love to learn
  • A competitive annual gross salary of minimum EUR 40k plus variable bonus Additional social benefits (fitness, public transport,..)

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

mySugr GmbH Logo

mySugr GmbH

Schottenfeldgasse 69/3
1070 Wien
Österreich