Clinical Evaluation Expert

vor 1 Woche

Wien, Österreich mySugr Vollzeit

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**:
As our dedicated **Clinical Evaluation Expert **you will be working on the Clinical Evaluation activities for the mySugr products and you will also take responsibility for Medical Risk Management activities 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 additional regulatory compliance related documentation (i.e., Post-Market Clinical Follow-Up Plans and Reports). 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 self-starter and a science-driven person, who passionate about minimising risks 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 development teams by being a key stakeholder in the Product 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
- Know the regulatory playground (MDR & FDA requirements) of medical devices in EU/USA
- Familiarity with ISO 14971 and associated standards (IEC 62304, etc.)
- Experience working on overlapping projects with your keen project management and organisational skills
- Be a self-starter that takes the initiative and eager to learn and expand their horizon
- 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, Science or Regulatory background and/or knowledge of the diabetes industry or other comparable health industries
- Great written and verbal communication skills in German

**Here's what you can expect from us**:

- 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 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 a

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