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

Director Quality Assurance, Regulatory Affairs and Vigilance