Head of Quality Management & Regulatory Affairs

Head of Quality Management & Regulatory Affairs

Job Title: Head of Quality Management & Regulatory Affairs
Contract Type: Permanent
Location: Zürich, Switzerland
Salary: Negotiable
Start Date: ASAP
Reference: HQ00118193_1580295750
Contact Name: Michael Burgstaller
Contact Email:
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:
  • 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: