mySugr GmbH
Clinical Evaluation Manager(m/w/x)
Full-timeFreelanceOn-siteJunior
Wien
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MYmySugr GmbH
Clinical Evaluation Manager(m/w/x)
Wien
Full-timeFreelanceOn-siteJunior
Nejo AI Summary
Clinical evaluation for mySugr/Roche products, authoring regulatory-compliant CERs for medical devices and IVDs at a healthcare innovation company. 1-3 years regulatory/CER writing experience for medical devices or IVDs required. Focus on early diagnosis and targeted treatments.
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 the achievement of the team and the company
- Technical understanding and love for innovative apps and/or software development
- Medical background and/or knowledge of the diabetes industry or similar health industries
- Knowledge of SAFe Agile ways of working
- Confident speaking in front of others
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
Work Experience
- 1 - 3 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Google Workspace
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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MYmySugr GmbH
Clinical Evaluation Manager(m/w/x)
Wien
Full-timeFreelanceOn-siteJunior
Nejo AI Summary
Clinical evaluation for mySugr/Roche products, authoring regulatory-compliant CERs for medical devices and IVDs at a healthcare innovation company. 1-3 years regulatory/CER writing experience for medical devices or IVDs required. Focus on early diagnosis and targeted treatments.
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 the achievement of the team and the company
- Technical understanding and love for innovative apps and/or software development
- Medical background and/or knowledge of the diabetes industry or similar health industries
- Knowledge of SAFe Agile ways of working
- Confident speaking in front of others
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
Work Experience
- 1 - 3 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Google Workspace
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.
About the Company
mySugr GmbH
Industry
Healthcare
Description
The company is committed to transforming healthcare through sustainable action and innovation, focusing on early diagnosis and targeted treatments.
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