Job DescriptionThe role
- The Senior Regulatory Affairs Associate role sits within the Government and Regulatory Affairs team, focusing on the management of regulatory submissions for new product registration. This role also focuses on the maintenance of existing products whilst ensuring compliance with the requirements of relevant regulations and legislation. All aspects of the role must be in compliance with company policy as well as meeting internal and external customer demands.
- Prepare and submit a range of registration applications for required products with efficiency and independence.
- Develop regulatory processes and drive process improvement to ensure regulatory compliance and improve process efficiencies.
- Advise on, maintain and process registration changes for required products.
- Provide strategic regulatory advice and transfer management for smooth incorporation of product acquisitions.
- Process regulatory actions in liaison with key stakeholders i.e QA, TGA and corporate requirements.
- Proven experience in Regulatory Affairs (or similar)
- Knowledge of Australian regulatory environments for medical devices (international regulatory knowledge desirable)
- Communication skills to effectively build relationships with key clients, stakeholders and members of government departments