Head of Quality & Regulatory – Australia and New Zealand
Ruth’s 20 years of experience in healthcare and regulatory compliance commenced when she joined Device Technologies in 1998 to implement administrative processes and systems for the rapidly growing Technical Services department. She was quickly appointed to the role of Regulatory Affairs Coordinator, project managing implementation of the Medical Device regulations. She became Regulatory Affairs Manager in 2004 with a broader responsibility for compliance of the company’s increasingly diverse range of products.
As Head of Quality & Regulatory, Ruth now leads a large team of professionals, ensuring prompt market access for new technologies in a challenging regulatory and reimbursement environment across Australia and New Zealand. Key areas of responsibility include the provision of regulatory strategy, ensuring compliance with pre-market assessment and post-market vigilance, reimbursement, code compliance and the company’s Quality Management System. More recently Ruth’s responsibilities have expanded to also include aspects of corporate governance and global compliance.
- Member of the Medical Technology Association of Australia (MTAA) Regulatory Sub-Committee (since 2000)
- Member of the MTAA Access Committee.
- Medical Device Summer School 'From Concept to CE Marking' - Management Forum UK
- Cert IV Compliance and Risk Management – GRCI