Quality and Regulatory Affairs Lead

Vor 4 Tagen


Frankfurt am Main, Hessen, Deutschland CM Medical Recruitment Vollzeit

Job Summary

CM Medical Recruitment is seeking a highly experienced Quality and Regulatory Affairs Lead to oversee the company's EMEAI warehouse facilities and third-party distributors across the region. The successful candidate will ensure high-quality and compliant distribution of medical devices, pharmaceuticals, and combination devices.

Key Responsibilities

  • Quality Management
    • Develop and implement quality management systems to ensure compliance with regulatory requirements.
    • Conduct regular audits and assessments to identify areas for improvement.
    • Collaborate with cross-functional teams to resolve quality-related issues.
  • Distribution Management
    • Oversee the distribution of medical devices, pharmaceuticals, and combination devices to ensure timely and compliant delivery.
    • Develop and maintain relationships with third-party distributors and suppliers.
    • Monitor distribution performance and quality to identify trends and areas for improvement.
  • Regulatory Compliance
    • Ensure compliance with FDA, European Union, and other international regulatory requirements.
    • Develop and implement regulatory strategies to ensure compliance with changing regulations.
    • Collaborate with regulatory affairs teams to resolve compliance-related issues.

Requirements

  • At least 8+ years of progressive work experience in quality and regulatory affairs.
  • Current, in-depth knowledge of FDA, European Union, and other international regulatory and quality requirements.
  • Advanced knowledge of regulatory frameworks and requirements for EU MDR.
  • Experience with hosting regulatory and notified body inspections.
  • Fluency in German and English.


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