Manager Quality Und Regulatory Compliance (m/w/d)

Roche UK

Mannheim, Germany
5+ years experience in regulated environment
Iso 13485 quality management system implementation
Medical device and ivd regulatory knowledge
This role serves as a strategic partner to the German sales organization, ensuring all innovations meet the highest quality and compliance standards

Job Summary

  • This role serves as a strategic partner to the German sales organization, ensuring all innovations meet the highest quality and compliance standards.
  • The position involves actively monitoring global and local legal trends to interpret and implement relevant regulations for medical devices and IVDs.
  • Roche offers a culture that encourages personal expression and genuine connections while providing diverse top benefits to support employee well-being.

Matching Summary

This role serves as a strategic partner to the German sales organization, ensuring all innovations meet the highest quality and compliance standards.

Skills & Requirements

Must-have

  • 5+ years experience in regulated environment
  • ISO 13485 quality management system implementation
  • Medical device and IVD regulatory knowledge
  • Internal auditor qualification required
  • Business continuity framework management

Nice-to-have

  • Agile project management methods
  • International team collaboration skills
  • Strategic advisory capabilities
  • Strong network building abilities
  • Growth mindset and customer orientation

Key Requirements

  • Degree in natural or engineering sciences
  • Minimum 5 years experience in MP/IVD sector
  • Qualification as internal auditor
  • Experience with ISO 14001 and ISO 27001
  • Fluency in German and English

Work Rights

Not specified

Tailored Resume

Cover Letter