Senior Regulatory Affairs Specialist
Fresenius Medical Care • Macquarie Park, Australia
Role 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:
+ 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.
The role supports 3 key business areas within ANZ– FMC Devices/Medicines (including Smithfield manufacturing), Packs, Seating.
**Responsibilities**
+ Maintain regulatory compliance across all ANZ device and medicine related pre- and po...
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:
+ 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.
The role supports 3 key business areas within ANZ– FMC Devices/Medicines (including Smithfield manufacturing), Packs, Seating.
**Responsibilities**
+ Maintain regulatory compliance across all ANZ device and medicine related pre- and po...