Head of Quality Management & Regulatory Affairs
Job Title: | Head of Quality Management & Regulatory Affairs |
Contract Type: | Permanent |
Location: | Zürich, Switzerland |
Industry: | |
Salary: | Negotiable |
Start Date: | ASAP |
Reference: | HQ00118193_1580295750 |
Contact Name: | Michael Burgstaller |
Contact Email: | m.burgstaller@sciproglobal.de |
Job Published: | January 29, 2020 11:02 |
Job Description
Our Client:
A pioneer in the field of high-resolution computed tomography in the Kanton Zurich.
Job Description:
- Responsible for the Quality Management System (QMS) and its related documentation, process description, training and implementation in alignment with internal and industry standards
- Ensure that all necessary systems and procedures are in place to satisfy all customer requirements and audits
- Introduce new systems and procedures where appropriate
- Internal QMS audits according to annual audit program
- CAPA Governance and Monitoring
- Manage Regulatory Affairs including external product registrations to ensure they comply to applicable standards in the market (CE, FDA, HC)
- Major QM-Standards: ISO 13485, ISO 9001, 21 CFR 820, MDSAP
- Main Regulatory Standards: MDD/MDR, 60601-1, 62304, 62366
The ideal candidate:
- University degree in Engineering or Physics
- Knowledge of MDR, MDSAP, FDA 820 preferred
- Experience in a similar position working for a medical device company
- Excellent communication skills in both English and German
Application process:
- CV to: m.burgstaller@sciproglobal.de
- Phone call including a presentation of the company
- I take over the whole application process (from interviews to contract negotiations)
- Discuss also other suiting options tailored towards your profile
My Contact:
- E-Mail: m.burgstaller@sciproglobal.de
- Tel: +41 43 508 92 17
- Xing: https://www.xing.com/profile/Michael_Burgstaller19/cv

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