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Quality and Regulatory Lead - Medical Devices

Quality and Regulatory Lead - Medical Devices

Michael PageGroot-Bijgaarden, BE
Il y a 14 jours
Description de poste

As the Quality and Regulatory lead, your responsibilities include :

  • Lead National Oversight : Manage SHS Quality and Regulatory (QT) activities for Belgium and Luxembourg.
  • Monitoring Regulatory : Represents SHS Country Organization in local country QT (QM and RA) community and related activities as well as monitoring the regulatory environment.
  • Maintain Government Relations : Act as main contact with authorities for Medical Devices / IVD products.
  • Manage Licensing : Ensure all necessary business and import licenses are valid.
  • Implement QMS : Maintain and enforce the Quality Management System.
  • Support Corrective Actions : Assist with safety corrective actions and post-market surveillance.
  • Maintain Certifications : Oversee ISO 9001 / 13485 certification and quality system improvements.
  • Ensure Supplier Compliance : Verify suppliers meet regulatory and compliance requirements and manage complaints.
  • Lead Performance System : Drive continuous improvement, efficiency, and quality performance metrics.

A successful Quality and Regulatory Lead should have :

  • A strong educational background in Life Science, or a related field.
  • Proven experience in quality management and regulatory affairs within the healthcare sector.
  • Excellent knowledge of regulatory standards in the life science / healthcare industry.
  • Leadership skills and the ability to mentor a team.
  • Strong communication skills and the ability to liaise with regulatory bodies.

    • Our client offers you :

  • An estimated annual salary of EUR 85,500 - 104,500.
  • A comprehensive benefits package.
  • A supportive work environment that encourages professional growth.
  • Opportunities to make a real impact in the life science industry and healthcare sector.

    • Take the next step in your career and become a leader in quality and regulatory affairs. Apply today for this exciting opportunity in Groot-Bijgaarden.

    Créer une alerte emploi pour cette recherche

    Quality Lead Medical • Groot-Bijgaarden, BE