Regulatory Affairs Specialist

5 days ago

Sydney, New South Wales, Australia Genea Biomedx Full time

We are seeking a Regulatory Affairs Specialist to join our team in Sydney, Australia. This role is responsible for ensuring regulatory compliance of medical devices with the Therapeutic Goods Administration (TGA) and other relevant global regulatory bodies. The ideal candidate will have strong knowledge of regulatory requirements, product registration processes, and a proactive approach to supporting business objectives.

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:

  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:

  1. Experience with international regulatory submissions (FDA, EU MDR, China NMPA, etc.).
  2. Knowledge of risk management and clinical evaluation requirements.
Seniority level

Entry level

Employment type

Full-time

Job function

Legal

Industries

Medical Equipment Manufacturing

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