Objectives:
- To support the strategic development and delivery of Association policies in matters pertinent to its expertise.
- To discuss operational issues facing the Association’s members in their interactions with the Therapeutic Goods Administration (TGA) in meeting the regulatory requirements for supplying medical technology in Australia.
- To develop and submit papers, proposals and feedback to the TGA on regulatory issues through the TGA/Industry Regulatory and Technical Consultative Forum.
- To support the Board in the strategic development and delivery of Association policies in matters pertinent to its expertise as determined by the Board from time to time.
- To develop regulatory-focused strategic initiatives for the Association, including:
- reviewing the effectiveness of the regulatory system for medical technology in Australia
- contributing to the Association’s involvement with international regulatory organisations
- liaising with Australian government departments and industry associations in Australia and overseas; and
- providing advice on the professional development of regulatory staff in the medical technology sector.
MTAA Lead: Jasjit Baveja, Associate Director, Policy
Member Name | Position Title | Company |
|---|---|---|
| Mahesh Datar (Chair) | Senior Manager, Regulatory Affairs | Medtronic Australasia Pty Ltd |
| Beth Roberts (Board Representative) | Managing Director | KLS Martin Australia 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 |
| Sugashine Jeganathan | Regulatory Affairs Manager | Bard Australia 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 |
| Merricc Edgar-Hughes | Head of Regulatory and Medical Affairs, ANZ | Bausch & Lomb (Australia) Pty Limited |
