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Expert Post Market Surveillance(m/w/x)
Description
In this role, you will dive into post-market data to identify trends and risks while ensuring compliance with regulations. Your expertise will drive improvements and support audits, making a significant impact on product safety and effectiveness.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Higher education degree in healthcare, life sciences, or business administration
- •Profound professional experience in regulatory compliance for MDR and IVDR
- •Strong understanding of risk management and vigilance reporting
- •Familiarity with quality management systems
- •Experience in designing and implementing PMS processes across multiple markets
- •Proven ability to influence and guide cross-functional teams
- •High level of proactivity, flexibility, and teamwork orientation
- •Excellent written and verbal communication skills in English
- •German highly beneficial
Education
Work Experience
approx. 4 - 6 years
Tasks
- •Collect and analyze post-market data
- •Identify trends and potential risks
- •Review relevant literature and scientific information
- •Ensure compliance with global and local post-market surveillance requirements
- •Prepare PMS documentation, including PMS, PMCF, PMPF, PSUR, and vigilance reports
- •Assess risks for medical devices and in vitro diagnostics
- •Recommend design or process changes based on surveillance insights
- •Support audits and inspections with PMS evidence
- •Provide guidance and training on PMS processes and tools
Languages
English – Business Fluent
German – Basic
Benefits
Career Advancement
- •Extensive career and development opportunities
- Greiner AGFull-timeOn-siteSeniorfrom 59,781.96 / yearKremsmünster
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Expert Post Market Surveillance(m/w/x)
The AI Job Search Engine
Description
In this role, you will dive into post-market data to identify trends and risks while ensuring compliance with regulations. Your expertise will drive improvements and support audits, making a significant impact on product safety and effectiveness.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Higher education degree in healthcare, life sciences, or business administration
- •Profound professional experience in regulatory compliance for MDR and IVDR
- •Strong understanding of risk management and vigilance reporting
- •Familiarity with quality management systems
- •Experience in designing and implementing PMS processes across multiple markets
- •Proven ability to influence and guide cross-functional teams
- •High level of proactivity, flexibility, and teamwork orientation
- •Excellent written and verbal communication skills in English
- •German highly beneficial
Education
Work Experience
approx. 4 - 6 years
Tasks
- •Collect and analyze post-market data
- •Identify trends and potential risks
- •Review relevant literature and scientific information
- •Ensure compliance with global and local post-market surveillance requirements
- •Prepare PMS documentation, including PMS, PMCF, PMPF, PSUR, and vigilance reports
- •Assess risks for medical devices and in vitro diagnostics
- •Recommend design or process changes based on surveillance insights
- •Support audits and inspections with PMS evidence
- •Provide guidance and training on PMS processes and tools
Languages
English – Business Fluent
German – Basic
Benefits
Career Advancement
- •Extensive career and development opportunities
About the Company
Greiner AG
Industry
Other
Description
Das Unternehmen ist weltweit führend in der Herstellung von Kunststoff- und Schaumstoffprodukten und entwickelt nachhaltige Produkte.
- Greiner AG
Team Leader Post Market Surveillance(m/w/x)
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Senior Expert Internal Audit(m/w/x)
Full-timeOn-siteSeniorfrom 72,171 / yearWien, Kremsmünster - Greiner Bio-One GmbH
Quality Engineer VACUETTE(m/w/x)
Full-timeOn-siteExperiencedfrom 47,532.24 / yearKremsmünster - Greiner AG
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