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GRGreiner AG

Expert Post Market Surveillance(m/w/x)

Kremsmünster
from 59,781.96 / year
Full-timeOn-siteSenior

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

  • EnglishBusiness Fluent
  • GermanBasic

Benefits

Career Advancement

  • Extensive career and development opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Greiner AG 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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