Regulatory Affairs Specialist

Job description

Scope of Role: The role is based in Sydney and may require some local and interstate travel. The role encompasses a range of pre and post market product activities and requires: The role supports 3 key business areas within ANZ– FMC Devices/Medicines (including Smithfield manufacturing), Packs, Seating. - interaction and negotiation with regulatory agencies in Australia and New Zealand; - collaboration across local, regional and cross functional regulatory, quality, clinical and pharmacovigilance teams to support the ANZ business and maintain regulatory compliance; - working closely with key internal stakeholders namely, S&M, Finance, Legal, Clinical, Supply chain and Technical teams to ensure no interruption to product supply within ANZ and to drive commercial initiatives and new products to market to grow the ANZ business. Responsibilities: - Maintain regulatory compliance across all ANZ device and medicine related pre- and post- marketing activities for the 3 key business areas - Review and maintain all medical device and medicine registration requirements to support the ANZ businesses within required timelines - Prepare and submit medical device applications to TGA and notifica...