SGS Australia Pty Ltd is seeking a Global Head of Operations to oversee the operational delivery of medical conformity assessment activities, ensuring compliance with regulatory standards. The role requires strong leadership and technical expertise in the medical device industry, with a focus on operational excellence and strategic resource management
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 oversee the operational delivery of medical conformity assessment activities, ensuring compliance with regulatory standards. The role requires strong leadership and technical expertise in the medical device industry, with a focus on operational excellence and strategic resource management.
Skills & Requirements
Must-have
EU MDR and EU IVDR compliance
ISO 13485 and MDSAP
UKCA requirements
Conformity assessment procedures
Resource planning and allocation
Nice-to-have
Client focus and integrity
Continuous development culture
Open corporate and international 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 roles
University degree in medicine, engineering, life sciences, or related field
Qualification as Lead Auditor or Product Assessor under EU MDR/EU IVDR
Qualification as Final Reviewer and Decision Maker under MDR or IVDR