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GRGreiner AG

Team Leader Post Market Surveillance(m/w/x)

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

In this role, you will lead a team of Post Market Surveillance experts, ensuring compliance with regulatory standards while influencing product lifecycle decisions. Your day-to-day responsibilities will involve overseeing documentation and assessing risks to enhance product management services.

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

EnglishBusiness FluentGermanBasic

Benefits

Career Advancement

  • Extensive career and development opportunities

Other Benefits

  • Generous benefits
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