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GR
Greiner AG
last mo.

Expert Post Market Surveillance(m/w/x)

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

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.

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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

Bachelor's degree

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

EnglishBusiness Fluent

GermanBasic

Benefits

Career Advancement

  • Extensive career and development opportunities
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