Regulatory Affairs Professional

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $61,998 - $135,122

As a Regulatory Affairs Specialist, you will play a pivotal role in ensuring compliance with medical device regulations and facilitating the commercialization of products in the Australia and New Zealand (ANZ) region.

The successful candidate will possess strong analytical skills, excellent written and verbal communication skills, and the ability to work effectively in a team environment. Additionally, experience with Australian Therapeutic Goods Administration (TGA) regulations is highly desirable.

This position offers an exciting opportunity for professional growth and development within a dynamic organization that prioritizes patient safety and product quality.

Key Responsibilities:
  • Develop and maintain sound regulatory strategies for market entry in ANZ
  • Compile, prepare, review, and submit regulatory dossiers to regulatory authorities
  • Manage changes to existing products to ensure continued compliance to regulations and supply continuity
  • Maintain up-to-date knowledge of regulatory requirements and changes in ANZ
  • Liaise with regulatory authorities and negotiate submission details
Requirements:
  • Minimum of 2 years of experience in regulatory affairs within the medical device industry
  • Bachelor's degree in science, engineering or a related field is desirable
  • Experience with international regulations and requirements is ideal (e.g., FDA, CE Marking)
Competencies:
  • Integrity and Compliance
  • Collaboration
  • Innovation
  • Accountability
  • Customer Focus
  • Adaptability and Resilience

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