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, alignment with EU Medical Device Regulations and international regulatory harmonisation forums (IMDF).
Objectives:
- Advise other MTAA strategic committees on regulatory matters and coordinate in areas of overlap (e.g. HTA review and regulatory review).
- Define the MTAA regulatory strategic plan and direction.
- Appoint the Chair and, if required, the Core Team of the Regulatory Forum.
- Consider and approve industry positions prepared and recommended by the Regulatory 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 Mc Caffrey | 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 |
| Giselle Rayman | Head of Regulatory Affairs & Commercial Quality, ANZ | Cardinal Health Australia 503 Pty Ltd |
| Ramakrishnan Kannan | Quality Engineering & Regulatory Affairs Manager, ANZ | LivaNova Australia Pty Ltd |
| Naeema Mohamed | Director, Regulatory Affairs & Commercial Quality, ANZ | Smith & Nephew Pty Ltd |
