Head of Quality Management & Regulatory Affairs

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