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:
As our dedicated Clinical Evaluation Expert you will lead the Clinical Evaluation activities for the mySugr products and you will take responsibility as medical support for the Risk Assessment process throughout the product development as well as the product life cycle. You will provide medical expertise to the organisation by delivering the Clinical Evaluation Reports (CERs) and CER-related documentation. With a passion for people and understanding their needs, you will work within cross functional teams providing guidance on the development and main product updates. We are looking for an energetic and science-driven person, passionate about minimising risk to the health of our patients. If this sounds like you, we’d love to talk to you about joining us on our mission.
Your upcoming mission:
- Leading the activity to develop and maintain the Clinical Evaluation Reports (CERs) and CER-related regulatory compliance documents; for example Post-Market Surveillance Plans (PMS Plans) and Post-Market Clinical Follow-Up Plans (PMCF Plans)
- Support the product development teams in the Risk Assessment processes as the medical expert
- Ensure continuous engagement and exchange of information with the Roche Medical Organisation and external key opinion leaders, with respect to CER/Medical Risk Management
- Stay up to date on new regulations and standards that affect Clinical Evaluations and Risk Management for medical devices
- Participate in regulatory inspections and Notified Body audits to represent the Clinical Evaluation activities
- Participate in international conferences as part of the mySugr medical team
Essential skills for your mission:
- 5+ years of relevant experience
- Formal education in relevant field (medicine, medical science background)
- Good understanding of the medical device environment, preferably software as a medical device
- Profound knowledge of ISO 14971 and familiarity with associated standards (IEC 62304, etc.)
- Know the playground of medical devices in EU/USA
- Experience working on overlapping projects with your keen project management and organisational skills
- Ability to manage Clinical Evaluation and Risk Management aspects of projects including planning, deliverables and priorities for company compliance
- Confident speaking in front of others and moderating Risk Management sessions
- Team spirit and love to work in an open, iterative and collaborative way
- Great written and verbal communication skills in English
- Technical understanding and love for innovative apps and/or software development
- Medical background and/or knowledge of the diabetes industry or other comparable health industries
- Great written and verbal communication skills in German
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!
Here at mySugr we are committed to providing a healthy, equal and inclusive working environment for our Monster Tamers to help them make diabetes suck less! 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 at mySugr - both professionally and personally.
Interested? Great. For this position we offer an annual gross salary starting from EUR 60k 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.