Regulatory Affairs Committee

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:
  1. reviewing the effectiveness of the regulatory system for medical technology in Australia
  2. contributing to the Association’s involvement with international regulatory organisations
  3. liaising with Australian government departments and industry associations in Australia and overseas; and
  4. 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 ManagerMedtronic Australasia
George Faithfull (Vice Chair)DirectorGeorgeFaithfull Advisory
Elizabeth Van Den AkkerRegulatory Affairs Director ANZAbbott Medical Australia
Ruth ShennanHead of Quality & Regulatory Device Technologies 
Maneesha PillayRegulatory Affairs DirectorEdwards Lifesciences
Sarah BotrosDirector, Government & RegulatoryStryker Australia
Rebecca GaudinRegulatory Affairs DirectorJohnson & Johnson Medical
Fleur WinsladeRA and Quality Assurance ManagerTerumo Australia
Hugh CameronRegulatory Affairs Director, ANZBard Australia
Hemangi MaldeRegulatory Affairs ManagerCook Australia
Rachel PatrickRegulatory Manager ANZMolnlycke Health Care
Katie-Lou BuscherLead Regulatory Affairs Specialist, APACNuVasive (Aus/NZ)
Iriny Ibrahem Senior Regulatory and Quality Manager ANZ Baxter Healthcare
Peter AustenQA/RA ManagerEvolution Surgical
Falko ThieleDirector Clinical and Regulatory AffairsBIOTRONIK Australia
Kellie ShawSenior Regulatory Affairs AssociateOlympus Australia
Jillianne McKenzieVice President, Regulatory AffairsField Orthopaedics
Morteza YousefiSenior Regulatory Affairs AssociateSolventum
Giselle RaymanHead of Regulatory Affairs & Commercial Quality, ANZCardinal Health Australia
Ramakrishnan KannanQuality Engineering & Regulatory Affairs Manager, ANZLivaNova Australia