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Quality and Regulatory Affairs Lead

vor 2 Monaten


Frankfurt am Main, Hessen, Deutschland CM Medical Recruitment Vollzeit

Job Summary

CM Medical Recruitment is seeking a highly skilled Quality and Regulatory Affairs Lead to oversee the distribution of medical devices, pharmaceuticals, and combination devices across the EMEAI region. The successful candidate will be responsible for ensuring high-quality and compliant distribution, while also supporting re-labelling activities and investigating deviations.

Key Responsibilities

  • Oversee the distribution of medical devices, pharmaceuticals, and combination devices across the EMEAI region
  • Ensure high-quality and compliant distribution, including support for re-labelling activities
  • Investigate deviations and implement corrective actions
  • Collaborate with Operations, Supply Chain, Business System Group, and EHS functions to develop and execute distribution management strategies
  • Monitor distribution performance and quality, and escalate trends or concerns
  • Advise on compliance risk and recommend corrective and preventive actions
  • Partner with distributors to support product complaints investigation and regulatory reporting activities
  • Host regulatory and notified body inspections and audits

Requirements

  • Current, in-depth knowledge of FDA, European Union, and other international regulatory and quality requirements pertaining to medical devices
  • Fluency in German and English