mySugr Senior Regulatory Affairs Manager (m/f/d)

at  Roche

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:

Vienna/Sant Cugat, Full time
We are looking for a Regulatory Affairs Manager with experience in the area of Software as a Medical Device and the respective 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 Software product development activities and ensure regulatory compliance.

ESSENTIAL SKILLS FOR YOUR MISSION:

• More than 5 years professional experience with current EU and/or FDA Medical Device regulations and guidelines
• Professional experience with ISO standards for Quality, Risk Management, Usability Engineering and Software product development
• Professional experience with class IIa, IIb Software as Medical Device registrations in EU and/or US
• 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

WHO WE ARE AND WHAT WE CARE ABOUT:

Here at mySugr and Roche 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 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.
Interested? Great. 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.
In Austria, mySugr has a legal obligation to disclose the minimum salary according to our collective agreement, which is gross 3.455 - per month for this position. But! Rest assured, we offer amazing competitive compensation packages which take into consideration current market trends, therefore you can expect a higher offer that reflects your experience level.

Please refer the Job description for details