Regulatory Affairs Manager

vor 3 Wochen

Wien, Österreich mySugr Vollzeit

Part Time Freelancer (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

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 **Regulatory Manager** **Freelancer** with experience in the area of Medical Device regulations. 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 and MDSAP certified; as a Regulatory Manager you will support our product development activities and ensure regulatory compliance.

**Essential skills for your mission**:

- More than 3 years professional experience with current EU and FDA Medical Device regulations and guidelines
- 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)
- A kick-ass office with a rooftop terrace, fully stocked kitchen and amazing barista coffee machines in the middle of Viennaoh, and did we mention the best team in the world

**Who we are and what we care about**:
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.

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.

Make sure to read our Privacy Notice for Applicants.

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