Clinical Development Lead – Diabetes Technology & Digital Health (m/f/d)

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Let’s build a healthier future, together! By combining our unique strengths, we are redefining healthcare through sustainable action and innovation. For a behind-the-scenes look, check out this video to see how we at Roche are making personalized health care a reality. The mySugr GmbH was acquired by Roche in 2017 and our Vienna office is one of Roche's global sites. You will be located here, in the heart of Vienna, no matter if you work on a mySugr®, Accu-Chek®, navify® or any other Roche product or solution. You can read more about the history of mySugr & Roche here . Here's what we're looking for: Serving as a Clinical Development Lead with specialized expertise in diabetology, your primary role is to provide strategic medical leadership throughout the product design, definition, and regulatory clearance lifecycle for the Roche Diabetes portfolio. You will act as the clinical authority guiding continuous glucose monitoring (CGM) sensors, predictive algorithms, and connected digital health solutions (Software as a Medical Device - SaMD) development. Core responsibilities center on defining intended use and indications, architecting clinical claims, translating medical unmet needs into design inputs, and authoring rigorous clinical evaluation documentation to secure regulatory approvals across the FDA and EU MDR landscapes. Postmarket medical complaint assessments round out your holistic, lifecycle responsibilities. Key Responsibilities: Working within the Clinical Development and Medical Affairs organization at Roche, you will contribute to the following concepts: Intended Use & Clinical Indication Definition: Formulate and refine the Intended Purpose, Indications for Use (IFU), target patient populations, clinical environments, contraindications for next-generation CGM hardware and mobile software applications. Clinical Claims Architecture: Contribute to the end-to-end clinical claim matrix for product launches and iterative software releases. Align commercial, regulatory, and scientific objectives to define competitive, compliant claims around sensor accuracy, glycemic variability, predictive alerts, and user outcomes (collaborating with Clinical Operations on study concepts when de novo data generation is required). Medical Input into Design & Development: Partner closely with R&D, systems engineering, and product management from early concept through design freeze. Translate endocrinology realities into formal User Needs and Design Inputs, actively participating in design reviews and determining clinical benefit-risk trade-offs. Algorithm & Physiological Validation: Serve as the clinical partner to data science and algorithm development teams. Provide medical rationale for glycemic thresholds, trend arrow heuristics, sensor calibration logic, predictive hypoglycemia/hyperglycemia alerts, and automated insulin delivery (AID) interoperability parameters. Human Factors & Usability Clinical Support: Provide medical expertise into usability engineering and human factors testing protocols, ensuring user interfaces, alert schemes, and onboarding workflows are safe, intuitive, and clinically sound for both laypersons and healthcare providers. Regulatory Dossiers & Clinical Evaluations (FDA & EU MDR): Own the clinical evaluation process under EU MDR (2017/745) and FDA pathways (Pre-Submissions, 510(k), De Novo, PMA). Author, update, and defend Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), and Post Market Clinical Follow-Up Plans and Reports. Health Authority & Notified Body Interaction: Serve as the medical expert in regulatory interactions, directly defending the clinical validity of the device design, the clinical benefit-risk profile, and state-of-the-art determinations during Notified Body reviews and FDA meetings. Risk Management Collaboration and Medical Safety: Work closely with Risk Management to score probabilities of occurrence of harm and severities of harm for software and hardware devices (ISO 1

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