Director Quality Assurance, Regulatory Affairs and Vigilance

Location Bonaduz, Imboden
Job type Permanent
Salary Negotiable
Contact Michael Burgstaller
Job ref ID125748_1589961881

Job description


A swiss medtech company for respiratory health.

Job Description:

Director Quality Assurance, Regulatory Affairs and Vigilance - Bonaduz, GR -

  • You are reporting directly to the CEO and are responsible for Regulatory Affairs, Quality Management and Vigilance by leading the respective teams (technically and disciplinary)
  • You develop the Regulatory Affairs strategy for global registrations including FDA, EU and Asia
  • As a member of the management team, and as the responsible person, you guide the transformation related to the MDR (Medical Device Reporting) requirements and set objectives for your department
  • You will promote quality awareness within the company and advise your colleagues on quality-related and regulatory requirements
  • You and your team work closely with the R&D department and provide early information about the effects of changes in the regulatory and quality requirements
  • By monitoring, interpreting and implementing regulatory developments, you will ensure compliance within the company


Director Quality Assurance, Regulatory Affairs and Vigilance - Bonaduz, GR -

  • You have a degree in natural sciences or engineering combined with several years (>10 years) of professional experience in Regulatory Affairs and Quality Management in the medical device industry
  • Your many years of experience in leadership and personnel management will help you to coach and develop your teams and plan the necessary resources
  • Profound knowledge and experiences with regulations: Major QM-Standards: ISO 13485, ISO 9001, 21CFR 820; main regulations: MDD/MDR, IEC60601-1 Serie, IEC62304, IEC14971 and approval procedures: 510(k), Health Canada
  • You are familiar with the relevant quality management tools, systems and methods and have a deep understanding of processes and quality
  • You have excellent English and German language and communication skills


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