Senior Regulatory Postmarket Compliance Specialist

3 days ago

Sydney, New South Wales, Australia beBeeCompliance Full time $180,000 - $220,000
Job Description

We are seeking a highly skilled professional to fill the role of Regulatory Compliance Specialist - Postmarket in our organization.


This position is responsible for ensuring compliance with global postmarket requirements by coordinating regulatory responses to field actions, preparing and managing submissions, and maintaining traceability across regulatory reports.


The successful candidate will have excellent leadership skills, be able to interpret evolving standards, contribute to risk assessments, and advise stakeholders on regulatory implications of emerging data and corrective actions.


This role represents Regulatory Affairs in postmarket forums, supports audit readiness, and fosters alignment between RA, Quality, Clinical, and regional teams.


Key Responsibilities:

  • 1.
Postmarket Regulatory LeadershipLead and coordinate regulatory responses to postmarket events (FSCAs, recalls). Draft, review, and report to regulatory health authorities (FDA, TGA, EU Notified Bodies, Health Canada, and others). Ensure accurate and timely documentation of reportable events in partnership with Quality, Clinical, and Product teams.
  • 2.
Global Compliance & Regulatory SubmissionPrepare, submit, and manage postmarket regulatory submissions and notifications. Maintain traceability across regulatory reports. Monitor submission progress and support follow-up actions and corrective actions.
  • 3.
Risk Analysis & Regulatory StrategyContribute to cross-functional postmarket risk assessments, linking complaint data, regulatory trends, and findings. Interpret evolving postmarket regulations and standards (e.g., EU MDR Chapter VII, ISO 13485, ISO 20416, MDSAP). Provide strategic guidance to stakeholders on regulatory implications of corrective actions and emerging data.
  • 4.
Cross-Functional Collaboration & Audit ReadinessRepresent RA in postmarket forums and cross-functional teams. Support audit readiness by ensuring documentation and processes meet regulatory requirements Partner with RA, Quality, Clinical, and Regional teams to drive alignment in postmarket processes.
  • 5.
Other Duties and RequirementsPerform additional responsibilities as required to support RA and RPSD objectives. Contribute to process improvements and special projects across Regulatory Affairs. Support inspections, audits, and team collaboration activities.

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