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Expert Post Market Surveillance(m/w/x)
Regulatory compliance for plastic and foam products, preparing PMS, PMCF, PMPF, PSUR, and vigilance reports at a global manufacturer. Profound experience in MDR and IVDR regulatory compliance and post-market surveillance process design across multiple markets required. Global project scope.
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
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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Benefits
Career Advancement
- Extensive career and development opportunities
Not a perfect match?
- Greiner AGFull-timeOn-siteSeniorKremsmünsterfrom 59,781.96 / year
- Greiner AG
Global Product Manager(m/w/x)
Full-timeOn-siteExperiencedKremsmünsterfrom 59,781.96 / year - Greiner Bio-One GmbH
Senior Expert Medical and Scientific Affairs(m/w/x)
Full-timeOn-siteSeniorKremsmünsterfrom 59,781.96 / year - Greiner Bio-One GmbH
Quality Engineer VACUETTE(m/w/x)
Full-timeOn-siteExperiencedKremsmünsterfrom 47,532.24 / year - Greiner AG
Senior Expert Internal Audit(m/w/x)
Full-timeOn-siteSeniorWien, Kremsmünsterfrom 72,171 / year
Expert Post Market Surveillance(m/w/x)
Regulatory compliance for plastic and foam products, preparing PMS, PMCF, PMPF, PSUR, and vigilance reports at a global manufacturer. Profound experience in MDR and IVDR regulatory compliance and post-market surveillance process design across multiple markets required. Global project scope.
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
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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
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.
Not a perfect match?
- Greiner AG
Team Leader Post Market Surveillance(m/w/x)
Full-timeOn-siteSeniorKremsmünsterfrom 59,781.96 / year - Greiner AG
Global Product Manager(m/w/x)
Full-timeOn-siteExperiencedKremsmünsterfrom 59,781.96 / year - Greiner Bio-One GmbH
Senior Expert Medical and Scientific Affairs(m/w/x)
Full-timeOn-siteSeniorKremsmünsterfrom 59,781.96 / year - Greiner Bio-One GmbH
Quality Engineer VACUETTE(m/w/x)
Full-timeOn-siteExperiencedKremsmünsterfrom 47,532.24 / year - Greiner AG
Senior Expert Internal Audit(m/w/x)
Full-timeOn-siteSeniorWien, Kremsmünsterfrom 72,171 / year