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Compliance Professional

3 weeks ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $130,000

Postmarket Regulatory Compliance Specialist

">Job Description:">

The Postmarket Regulatory Compliance Specialist plays a critical role in ensuring the safety and efficacy of medical devices after market launch. This includes leading regulatory responses to post-market events, drafting and submitting reports to regulatory health authorities, and maintaining accurate documentation of reportable events.

">Key Responsibilities:">
  • ">
  • Lead and coordinate regulatory responses to post-market events, including field safety corrective actions and recalls.">
  • Draft, review, and submit reports to regulatory health authorities such as the FDA, TGA, and EU Notified Bodies.">
  • Maintain accurate and timely documentation of reportable events in partnership with Quality, Clinical, and Product teams.">
  • Prepare, submit, and manage post-market regulatory submissions and notifications.">
  • Conduct risk assessments and provide strategic guidance on regulatory implications of corrective actions and emerging data.">
  • Represent Regulatory Affairs in post-market forums and cross-functional teams.">
">Requirements:">
  • ">
  • Bachelor's degree in biomedical engineering, life sciences, or a related field.">
  • Minimum 6 years of experience in Regulatory Affairs or Quality Assurance in a regulated medical device environment.">
  • Expertise in post-market regulatory functions, including vigilance reporting, complaint handling, and FSCAs.">
  • Strong technical writing and documentation skills, with attention to regulatory accuracy and detail.">
  • Proven ability to work cross-functionally on risk, complaints, or field actions.">
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