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Clinical Evaluation Manager(m/w/x)
Authoring regulatory-compliant CERs for mySugr/Roche medical devices. 1-3 years regulatory/CER writing for medical devices or IVDs required. Flexible workplace.
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
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
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
Not a perfect match?
- mySugr GmbHFull-timeFreelanceOn-siteJuniorWien
- mySugr GmbH
Senior Medical Manager / Senior Clinical Evaluation Manager(m/w/x)
Full-timeOn-siteSeniorWienfrom 3,843 / month - mySugr GmbH
Senior Medical Manager / Senior Clinical Evaluation Manager(m/w/x)
Full-timeOn-siteSeniorWienfrom 3,843 / month - mySugr GmbH
Medical Device Risk Manager(m/w/x)
Full-time/Part-timeFreelanceOn-siteExperiencedWien - mySugr GmbH
Medical Device Risk Manager(m/w/x)
Full-time/Part-timeFreelanceOn-siteExperiencedWien
Clinical Evaluation Manager(m/w/x)
Authoring regulatory-compliant CERs for mySugr/Roche medical devices. 1-3 years regulatory/CER writing for medical devices or IVDs required. Flexible workplace.
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
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
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
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.
Not a perfect match?
- mySugr GmbH
Clinical Evaluation Manager(m/w/x)
Full-timeFreelanceOn-siteJuniorWien - mySugr GmbH
Senior Medical Manager / Senior Clinical Evaluation Manager(m/w/x)
Full-timeOn-siteSeniorWienfrom 3,843 / month - mySugr GmbH
Senior Medical Manager / Senior Clinical Evaluation Manager(m/w/x)
Full-timeOn-siteSeniorWienfrom 3,843 / month - mySugr GmbH
Medical Device Risk Manager(m/w/x)
Full-time/Part-timeFreelanceOn-siteExperiencedWien - mySugr GmbH
Medical Device Risk Manager(m/w/x)
Full-time/Part-timeFreelanceOn-siteExperiencedWien