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:
    • a) reviewing the effectiveness of the regulatory system for medical technology in Australia
    • b) contributing to the Association’s involvement with international regulatory organisations
    • c) liaising with Australian government departments and industry associations in Australia and overseas, and
    • d) providing advice on the professional development of regulatory staff in the medical technology sector.

MTAA Secretary: Jasjit Baveja, Senior Manager Regulatory Affairs

Member Name 

Position Title

Company 

Mahesh Datar (Chair)Snr Manager, Regulatory AffairsMedtronic 
George Faithfull (Vice Chair)DirectorGeorgeFaithfull Advisory P/L
Elizabeth Van Den AkkerRegulatory Affairs Manager, ANZAbbott Vascular 
Renee CottaDirector, Asia Pacific Regulatory Affairs & QARA ANZBoston Scientific 
Ruth ShennanHead of Quality and Regulatory - Australia & New ZealandDevice Technologies 
Rebecca GaudinDirector Regulatory AffairsJohnson & Johnson 
Sarah BotrosRegulatory Affairs & Quality Assurance ManagerStryker
Fleur WinsladeSnr Manager, Regulatory & ReimbursementTerumo 
Juliana WilliamRegulatory Affairs ManagerBaxter Healthcare
Maneesha PillayDirector Regulatory Affairs, ANZEdwards Lifesciences 
Sarah TimmsSenior Regulatory Affairs ManagerFresenius Medical Care
Romit SinghRA/QA Manager - ANZArthrex Australia Pty Ltd
Leanne HartgeRegulatory Affairs and Quality Compliance Manager, ANZ3M Australia Pty Ltd
Falko ThieleDirector Clinical and Regulatory AffairsBIOTRONIK Australia
Giselle RaymanHead of Regulatory Affairs ANZ & Commercial Quality APACCardinal Health
Lynda NottingManager, Regulatory, Quality & ComplianceCommercial Eyes Pty Ltd
Iriny IbrahemRegulatory Affairs Manager Smith & Nephew Pty Ltd
Richard MalynRA/QA ManagerLima Orthopaedics