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Interested in this job?

Ooooh, exciting, right? Be our new Clinical Evaluation Expert - Freelancer (m/f/d) and help us make diabetes suck less.

Clinical Evaluation Expert - Freelancer (m/f/d)

Vienna Head Office
Medical

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!

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. 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:

As our dedicated Clinical Evaluation Expert - Freelancer you will be working on 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:

  • Develop and maintain the Clinical Evaluation Reports (CERs) and CER-related regulatory compliance documents; for example Post-Market Clinical Follow-Up Plans and Reports
  • Support the product development teams in the Risk Management activities as the medical expert 
  • Ensure continuous engagement and exchange of information with the Roche Medical Organisation and external key opinion leaders, with respect to Clinical Evaluation/Post-Market Clinical Follow-Up/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

Essential skills for your mission:

  • 4+ 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
  • Familiarity with ISO 14971 and 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
  • Experience in medical/scientific writing 
  • Confident speaking in front of others
  • Team spirit and love to work in an open, iterative and collaborative way
  • Great written and verbal communication skills in English

Bonus Skills:

  • 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)
  • Flexible working hours and home office policy
  • 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. 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.

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Interested in this job?

Ooooh, exciting, right? Be our new Clinical Evaluation Expert - Freelancer (m/f/d) and help us make diabetes suck less.

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