Objectives:
- To support the in 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 | Company |
---|---|---|
Mahesh Datar (Chair) | Regulatory Affairs Snr Manager | Medtronic Australasia |
George Faithfull (Vice Chair) | Director | GeorgeFaithfull Advisory |
Elizabeth Van Den Akker | Regulatory Affairs Director ANZ | Abbott Medical Australia |
Ruth Shennan | Head of Quality & Regulatory | Device Technologies |
Maneesha Pillay | Regulatory Affairs Director | Edwards Lifesciences |
Sarah Botros | Director, Government & Regulatory | Stryker Australia |
Rebecca Gaudin | Regulatory Affairs Director | Johnson & Johnson Medical |
Fleur Winslade | RA and Quality Assurance Manager | Terumo Australia |
Hugh Cameron | Regulatory Affairs Director, ANZ | Bard Australia |
Hemangi Malde | Regulatory Affairs Manager | Cook Australia |
Rachel Patrick | Regulatory Manager ANZ | Molnlycke Health Care |
Katie-Lou Buscher | Lead Regulatory Affairs Specialist, APAC | NuVasive (Aus/NZ) |
Iriny Ibrahem | Senior Regulatory and Quality Manager ANZ | Baxter Healthcare |
Peter Austen | QA/RA Manager | Evolution Surgical |
Falko Thiele | Director Clinical and Regulatory Affairs | BIOTRONIK Australia |
Kellie Shaw | Senior Regulatory Affairs Associate | Olympus Australia |
Jillianne McKenzie | Vice President, Regulatory Affairs | Field Orthopaedics |
Morteza Yousefi | Senior Regulatory Affairs Associate | Solventum |
Giselle Rayman | Head of Regulatory Affairs & Commercial Quality, ANZ | Cardinal Health Australia |
Ramakrishnan Kannan | Quality Engineering & Regulatory Affairs Manager, ANZ | LivaNova Australia |