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Regulatory Compliance Specialist

2 weeks ago

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

At Genea Biomedx, we are seeking a highly skilled Regulatory Compliance Specialist 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 the Therapeutic Goods Administration (TGA) and other global regulatory bodies.

Key Responsibilities:
  1. Prepare, submit, and manage regulatory approvals for medical devices in Australia, including TGA registrations and ARTG listings.
  2. Maintain and update regulatory documentation, technical files, and risk assessments.
  3. Collaborate with cross-functional teams, including R&D, Quality, and Commercial teams, to ensure regulatory requirements are met throughout the product lifecycle.
  4. Monitor regulatory changes and provide guidance on impact and implementation strategies.
  5. Assist in post-market surveillance, adverse event reporting, and compliance audits.
  6. Support international product registrations, including FDA, CE Marking, and other global regulatory requirements.
  7. Communicate with regulatory agency and manage inquiries related to submissions and compliance.

Qualifications & Experience:

To be successful in this role, you will need:
  1. Bachelor's degree in Biomedical Engineering, Regulatory Affairs, or a related field.
  2. 2+ 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 regulatory submissions, product registration, and compliance documentation.
  5. Ability to interpret and apply regulatory requirements effectively.
  6. Excellent attention to detail, analytical skills, and problem-solving abilities.
  7. Strong communication skills and ability to work in a cross-functional team.

Preferred Qualifications:

While not required, it is desirable if you have experience with international regulatory submissions (FDA, EU MDR, China NMPA, etc.) and knowledge of risk management and clinical evaluation requirements.

If you are a motivated and experienced regulatory professional looking to take your career to the next level, please apply today