Quality Assurance Manager

7 days ago


City of Monash, Australia Osteon Medical Full time
About the Job

We are seeking a detail-oriented and proactive Regulatory Compliance Specialist on a 12-month parental leave contract. The role is pivotal in managing quality systems, regulatory submissions, and driving continuous compliance improvements throughout the product lifecycle—from design to post-market surveillance and support.

Key Responsibilities
  • Improve, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485 and relevant regulatory requirements.
  • Prepare, review, and submit regulatory submissions for new product approvals and registrations, and maintain existing registrations and database entries.
  • Manage and assist with internal and external audits, and address non-conformances.
  • Lead the investigation and resolution of nonconformities and customer complaints, and CAPAs as per defined procedures.
  • Monitor regulatory changes and provide actionable guidance to maintain compliance.
  • Manage changes related to products and the QMS according to the defined Change Control Process.


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