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mySugr GmbH
2mo ago

Clinical Evaluation Manager(m/w/x)

Wien
Full-timeFreelanceOn-siteJunior

Description

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.

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Requirements

  • •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

Education

Master's degree

Work Experience

1 - 3 years

Tasks

  • •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 & Technologies

Google Workspace

Languages

English – Business Fluent

Benefits

Ergonomic Workplace

  • •Healthy working environment

Family Support

  • •Family friendly career paths

Sustainability Focus

  • •Sustainability focus

Healthcare & Fitness

  • •Healthy lifestyle

Flexible Working

  • •Flexible workplace

Learning & Development

  • •Culture of learning and sharing

Informal Culture

  • •Open and candid feedback

Career Advancement

  • •Opportunities for professional growth
  • •Opportunities for personal growth
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of mySugr GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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