SGS Australia Pty Ltd is seeking a Global Head of Operations to lead the operational delivery of medical schemes in compliance with various regulatory standards. The role requires extensive experience in the medical device industry and strong leadership skills, with the flexibility to work fully remote from anywhere in Europe
Job Summary
Leading and coordinating the operational delivery of all medical schemes including MDR and IVDR conformity assessment activities under SGS NB 1639.
Ensures the effective performance of clinical, audits, technical, and product assessment functions, driving operational excellence, regulatory compliance, and strategic resource management.
We offer a dynamic work environment in a leading global company and invest in our employees for the long term, supporting your development within the company.
Matching Summary
Match Score: 85
SGS Australia Pty Ltd is seeking a Global Head of Operations to lead the operational delivery of medical schemes in compliance with various regulatory standards. The role requires extensive experience in the medical device industry and strong leadership skills, with the flexibility to work fully remote from anywhere in Europe.
Skills & Requirements
Must-have
EU MDR / EU IVDR compliance
ISO 13485, MDSAP, UKCA
Conformity assessment procedures
Technical resource management
Regulatory authority liaison
Nice-to-have
Client focus and integrity
Continuous development culture
International corporate culture
Sustainability approach
Key Requirements
Minimum 10 years in medical device/IVD industry
At least 5 years senior leadership in Notified Body
Minimum 2 years in revenue-focused leadership
University degree in medicine, engineering, life sciences, or related field
Qualification as Lead Auditor or Product Assessor
Qualification as Final Reviewer and Decision Maker