Beschreibung

As a Clinical Evaluation Manager, you will oversee comprehensive clinical evaluation activities, ensuring device safety and performance through literature reviews and regulatory reporting. Your expertise will guide risk management throughout the product lifecycle while optimizing team workflows.

Anforderungen

• •1-3 years of experience with regulatory/CER writing for medical devices or in vitro diagnostics
• •Advanced degree in medicine, life sciences, pharmacology, biomedical engineering, biostatistics/epidemiology, or related fields
• •Strong analytical and problem-solving skills
• •Excellent written and verbal communication skills in English
• •Detail-oriented with ability to manage multiple tasks and deadlines
• •Capability to make risk-based decisions
• •Basic understanding of clinical research and biostatistics
• •Proficiency in Google Workspace
• •Ability to work independently and as part of a team in an open, collaborative way
• •Eagerness to learn and contribute to team and company achievement
• •Technical understanding and love for innovative apps and/or software development
• •Medical background and/or knowledge of diabetes industry or similar health industries
• •Knowledge of SAFe Agile ways of working
• •Confident speaking in front of others

Aufgaben

• •Lead end-to-end clinical evaluation activities for mySugr/Roche products
• •Conduct systematic literature reviews
• •Appraise data for clinical evaluations
• •Author regulatory-compliant Clinical Evaluation Reports (CERs)
• •Provide expert medical input for risk management and vigilance
• •Support the product lifecycle from development to post-market
• •Facilitate team backlog grooming
• •Prioritize deliverables for efficient working practices

Tools & Technologien

Benefits