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Team Leader Post Market Surveillance(m/w/x)
Leading an expert team for regulatory compliance of plastic and foam products at a global manufacturer. Profound experience in MDR/IVDR regulatory compliance required. Cross-functional interface with RA, Quality, Product Management.
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
- Extensive experience in designing and implementing PMS processes across multiple markets
- Proven experience in managing cross-functional projects
- Ideally first experience of leading teams
- High level of proactivity, flexibility, and teamwork orientation
- Excellent written and verbal communication skills in English
- German highly beneficial
Tasks
- Lead and develop a team of Post Market Surveillance experts
- Act as the main interface between PMS, Regulatory Affairs, Quality, and Product Management
- Communicate PMS findings and recommendations to influence product lifecycle decisions
- Define and maintain PMS processes to ensure regulatory compliance
- Oversee timely completion of PMS documentation, including PMS, PMCF, PMPF, PSUR, and vigilance reports
- Assess risks relevant to medical devices and in vitro diagnostics within PMS documents
- Manage the budget for the PMS team
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Benefits
Career Advancement
- Extensive career and development opportunities
Other Benefits
- Generous benefits
Not a perfect match?
- Greiner AGFull-timeOn-siteSeniorKremsmünsterfrom 59,781.96 / year
- Greiner AG
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Team Leader Post Market Surveillance(m/w/x)
Leading an expert team for regulatory compliance of plastic and foam products at a global manufacturer. Profound experience in MDR/IVDR regulatory compliance required. Cross-functional interface with RA, Quality, Product Management.
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
- Extensive experience in designing and implementing PMS processes across multiple markets
- Proven experience in managing cross-functional projects
- Ideally first experience of leading teams
- High level of proactivity, flexibility, and teamwork orientation
- Excellent written and verbal communication skills in English
- German highly beneficial
Tasks
- Lead and develop a team of Post Market Surveillance experts
- Act as the main interface between PMS, Regulatory Affairs, Quality, and Product Management
- Communicate PMS findings and recommendations to influence product lifecycle decisions
- Define and maintain PMS processes to ensure regulatory compliance
- Oversee timely completion of PMS documentation, including PMS, PMCF, PMPF, PSUR, and vigilance reports
- Assess risks relevant to medical devices and in vitro diagnostics within PMS documents
- Manage the budget for the PMS team
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Benefits
Career Advancement
- Extensive career and development opportunities
Other Benefits
- Generous benefits
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
Expert 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 - polytec-group.com
Team Leader Finishing/packaging(m/w/x)
Full-timeOn-siteSeniorHörschingfrom 38,000 / year - Connex Group
Teamlead Customer Success - Loyalty Programme(m/w/x)
Full-timeOn-siteManagementWelsfrom 3,000 / month - Fronius International GmbH
Teamleitung Industrial Engineering - Optimization(m/w/x)
Full-timeOn-siteManagementSattledtfrom 4,341.85 / month