Purpose:
To develop industry positions and decide on the strategic direction of MTAA on regulatory matters within the scope of the Therapeutic Goods Act, the Medical Devices Regulations and the Advertising Code.
Objectives:
- Advise other MTAA strategic committees on regulatory matters and coordinate in areas of overlap.
- Define the MTAA regulatory strategic plan and direction.
- Appoint the Chair of the Regulatory Affairs Forum, Quality Assurance Forum and Clinical Affairs Forum.
- Consider and approve industry positions prepared and recommended by the Regulatory Forum, Quality Assurance Forum and the Clinical Investigations Forum.
- Manage the interaction with TGA via the RegTech forum.
MTAA Lead: Jasjit Baveja, Director, Regulatory and Industry Policy
Name | Position Title | Company |
|---|---|---|
| Mahesh Datar (Chair) | Senior Manager, Regulatory Affairs | Medtronic Australasia Pty Ltd |
| Colm O'Rourke | General Manager | MDSS AU Pty Ltd |
| Fleur Winslade | Regulatory Affairs & Quality Assurance Manager | Terumo Australia Pty Ltd |
| Romit Singh | RAQA Manager - ANZ | Zimmer Biomet Pty Ltd |
| Maneesha Pillay | Director, Regulatory Affairs | Edwards Lifesciences Pty Ltd |
| Sebastian Castiblanco | Regulatory Affairs Manager, Australia and New Zealand | Boston Scientific Pty Ltd |
| Elizabeth Van Den Akker | Regulatory Affairs Director | Abbott Medical Australia Pty Ltd |
| Ruth Shennan | Head of Quality and Regulatory | Device Technologies Australia Pty Ltd |
| Rebecca Gaudin | Director of Regulatory Affairs | Johnson & Johnson MedTech |
| Hemangi Malde | Senior Manager Regulatory Affairs | Cook Medical Australia Pty Ltd |
| Leanne Hartge | Head of Regulatory Affairs and Compliance, ANZ | Solventum |
| Marie McCaffrey | Regulatory Affairs Manager | Stryker Australia Pty Ltd |
| Falko Thiele | Director Clinical and Regulatory Affairs | BIOTRONIK Australia Pty Ltd |
| Kellie Shaw | Senior Regulatory Affairs Associate | Olympus Australia Pty Ltd |
| Jillianne McKenzie | Vice President, Regulatory Affairs | Field Orthopaedics Pty Ltd |
| Hugh Cameron | Senior Director Regulatory Affairs ANZ | Exactech Australia Pty Ltd |
| Ramakrishnan Kannan | Quality Engineering & Regulatory Affairs Manager, ANZ | LivaNova Australia Pty Ltd |
| Richard Mylan | Senior Regulatory Affairs Manager | B.Braun Australia Pty Ltd |
| Angell Zhang | Managing Counsel - JAPAC | Oracle Corporation Australia |
| Grant Woolcott | Senior RAQA Manager - ANZ & SEA+ | Teleflex Medical Australia Pty Ltd |
| Tanya Spence | Head of Regulatory and Quality APAC | Philips Electronics Australia Pty Ltd |
| Meryl Musson | Head of QA/RA ANZ | Vantive Pty Ltd |
| Sugashine Jeganathan | Director of Quality and Regulatory Affairs | Conmed Linvatec Australia Pty Ltd |
