Global Regulatory Affairs Lead

7 days ago


Sydney, New South Wales, Australia Genea Biomedx Full time
Job Opportunity

Genea Biomedx is seeking a highly skilled Global Regulatory Affairs Lead to join our team in Sydney, Australia. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements, including those set by the Therapeutic Goods Administration (TGA).

Key Responsibilities:
  1. Develop, implement, and maintain global regulatory strategies to ensure compliance with regulatory requirements.
  2. Lead cross-functional teams to prepare, submit, and manage regulatory approvals for medical devices worldwide.
  3. Collaborate with regulatory agencies and manage inquiries related to submissions and compliance.
  4. Monitor regulatory changes and provide guidance on impact and implementation strategies.
  5. Support international product registrations, including FDA, CE Marking, and other global regulatory requirements.

Requirements:

To be successful in this role, you will need:
  1. Bachelor's degree in Biomedical Engineering, Regulatory Affairs, or a related field.
  2. 5+ years of experience in regulatory affairs, preferably in the medical device industry.
  3. Strong understanding of TGA regulations, and medical device quality management systems.
  4. Experience with global regulatory strategies, regulatory submissions, and compliance documentation.
  5. Ability to interpret and apply regulatory requirements effectively.
  6. Excellent communication skills and ability to work in a cross-functional team.

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