Affiliate Head Of Quality And Regulatory Affairs - Roche Diagnostics

Roche UK

Hod Hasharon, Israel
Quality management system
Iso 9001:2015 certification
Gmp/gdp quality management
This role is critical in ensuring the highest standards of GMP/GDP Quality Management within our organization

Job Summary

  • This role is critical in ensuring the highest standards of GMP/GDP Quality Management within our organization.
  • Act as the primary point of contact for the Quality Management System for both internal and external stakeholders and authorities.
  • Responsibility for the regulatory processes of the company’s products, including regulatory approval of new products, changes in registration and renewal of existing licenses.

Matching Summary

This role is critical in ensuring the highest standards of GMP/GDP Quality Management within our organization.

Skills & Requirements

Must-have

  • Quality Management System
  • ISO 9001:2015 certification
  • GMP/GDP Quality Management
  • Regulatory Affairs
  • Lead Auditor
  • IVDR/MDR compliance

Nice-to-have

  • innovative and creative
  • customer and colleague expectations
  • foster creativity
  • explore new possibilities

Key Requirements

  • 5-10 years experience
  • BA/BS, MS, or PhD
  • Hebrew and English communication

Work Rights

Not specified

Tailored Resume

Cover Letter