Director Quality Assurance, Regulatory Affairs and Vigilance
Job Title: | Director Quality Assurance, Regulatory Affairs and Vigilance |
Contract Type: | Permanent |
Location: | Bonaduz, Imboden |
Industry: | |
Salary: | Negotiable |
Reference: | ID125748_1589961881 |
Contact Name: | Michael Burgstaller |
Contact Email: | m.burgstaller@sciproglobal.de |
Job Published: | May 20, 2020 09:04 |
Job Description
Client:
A swiss medtech company for respiratory health.
Job Description:
Director Quality Assurance, Regulatory Affairs and Vigilance - Bonaduz, GR - Indeed.ch
- 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
Candidate:
Director Quality Assurance, Regulatory Affairs and Vigilance - Bonaduz, GR - Indeed.ch
- 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
Process:
Send your full application package to: m.burgstaller@sciproglobal.de

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