Senior Postmarket Compliance Professional

2 weeks ago


Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $150,000
Postmarket Compliance Specialist

This role is central to ensuring timely and compliant access to global markets.

Main Responsibilities:
  1. Provide leadership and guidance on regulatory activities that safeguard products once they are on the market.
  2. Coordinate regulatory responses to postmarket events (FSCAs, recalls) by drafting, reviewing, and reporting to regulatory health authorities (FDA, TGA, EU Notified Bodies, Health Canada, etc).
  3. Prepare, submit, and manage postmarket regulatory submissions and notifications while maintaining traceability across regulatory reports.
  4. Contribute to cross-functional postmarket risk assessments linking complaint data, regulatory trends, and findings.
  5. Represent RA in postmarket forums and cross-functional teams, ensuring documentation and processes meet regulatory requirements.

This role requires a strong technical background in biomedical engineering, life sciences, or a related field, along with significant experience in Regulatory Affairs or Quality Assurance in a regulated medical device environment.

The ideal candidate will possess excellent communication skills, be able to work effectively in a team environment, and have a keen eye for detail. If you are passionate about regulatory compliance and want to make a meaningful contribution to a dynamic team, we encourage you to apply.



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