Regulatory Postmarket Compliance Professional

7 days ago

Sydney, New South Wales, Australia beBeeCompliance Full time $120,000 - $170,000
About Regulatory Postmarket Compliance

We pioneer innovative health technologies that transform lives daily. Our devices span the globe and connect patients, providers, and data to improve healthcare outcomes.

Our team ensures timely and compliant access to global markets. We work across more than 140 countries to deliver safe and effective innovations that improve quality of life.

Key ResponsibilitiesPostmarket Regulatory Leadership
  • Lead regulatory responses to postmarket events.
  • Draft, review, and report to regulatory health authorities.
  • Ensure accurate documentation of reportable events in partnership with Quality and Product teams.
Global Compliance & Regulatory Submission
  • Prepare, submit, and manage postmarket regulatory submissions and notifications.
  • Maintain traceability across regulatory reports.
  • Monitor submission progress and support follow-up actions.
Risk Analysis & Regulatory Strategy
  • Contribute to cross-functional postmarket risk assessments.
  • Interpret evolving regulations and standards.
  • Provide guidance on regulatory implications of corrective actions and emerging data.
Cross-Functional Collaboration & Audit Readiness
  • Represent Regulatory Affairs in postmarket forums and cross-functional teams.
  • Support audit readiness by ensuring documentation meets regulatory requirements.
  • Partner with teams to drive alignment in postmarket processes.

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