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Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $130,000
Senior Regulatory Affairs Associate Job Description

This is an exciting career opportunity to join a dynamic team as a Senior Regulatory Affairs Associate, playing a vital role in the strategic development and operation of regulatory submissions for high-priority products.

You will be responsible for managing end-to-end regulatory submissions, including interactions with local authorities, and leading regulatory strategy and compiling technical files, primarily adapted from EU documentation.

The key responsibilities of this role include:

  • Preparing Documentation: Preparing high-quality documentation for Class III IVD, Class IIb, and Class III Medical Devices.
  • Regulatory Review: Reviewing local documentation and assessing non-conformance where required.
  • Evaluating Regulatory Impact: Evaluating the regulatory impact of product and process changes.
  • Compliance Review: Reviewing promotional and advertising materials for compliance.
  • Regulatory Support: Providing regulatory support to cross-functional teams, including commercial and market access.

To succeed in this role, you will require:

  • Tertiary qualification in a scientific or healthcare-related discipline.
  • A minimum of 3 years of experience in Regulatory Affairs, specifically in medical devices.
  • Strong technical writing skills, with expertise in creating regulatory files.
  • Experience working on local authority submissions and promotional material reviews.
  • Excellent communication skills, with the ability to work effectively across functions.
  • The ability to manage priorities in a fast-paced environment and work independently.

This is an excellent opportunity to join a growing team that values innovation, autonomy, and open communication. As a Senior Regulatory Affairs Associate, you will have the opportunity to make a significant contribution to the development and success of our business.