Head of Quality/Regulatory

Salary/Rate:€120,000 - €170,000
Job type:Perm
Town/City:Mainz
Country:Germany
Business Sectors:Quality
Job ref:25195
Post Date:22. 05. 2024
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About the Role

Head of Quality and Regulatory Affairs

Are you passionate about Quality Management and Regulatory Affairs?

Are you a hands-on leader, with expertise in managing RAQM processes in the diagnostics field?

Are you looking for a role where you can have the freedom to really drive change and make a difference for your team?

Apply now to join my client, a leading international diagnostics company, as their new Head of Quality and Regulatory Affairs!

Ready to put your skills to work?

Your Tasks:
  • Maintain QMS and ensure compliance with applicable quality & regulatory requirements
  • Provide leadership, guidance, and mentoring to Quality and Regulatory teams
  • Identify and implement initiatives to enhance the quality system and drive efficiencies
  • Timely resolution of non-conformances and complaints
  • Budget & Stakeholder Management incl. communication with Notified Bodies

Your profile:
 
  • Master or higher degree in science or a related field
  • Min. 10 years’ experience in quality assurance and control, preferably in the medical device or diagnostic industry.
  • Extensive knowledge of ISO13485, FDA 21 CFR 820, IVDR/MDR
  • Demonstrated ability to drive change, implement best practices, and achieve results.
  • Fluent German and English

Please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management.

vivien.urban@adaptivelifescience.com
+49 30 16639819

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