Global Quality Assurance and Regulatory Affairs Professional

4 days ago

Sydney, New South Wales, Australia beBeeQuality Full time $100,000 - $120,000

Job Title: Quality Assurance and Regulatory Affairs Specialist

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About the Role

This role offers a unique opportunity to work within a global medical device organization, collaborating with local and global stakeholders. The successful candidate will be responsible for maintaining and implementing new process improvements to the Quality Management System (QMS) system, overseeing quality release, labelling, complaints investigations, change control, Non-Conforming Reports (NCRs), and Corrective Action Preventive Actions (CAPA). They will also manage local QC testing with external laboratories when required, prepare the audit schedule, and lead internal and external audits.

Key Responsibilities

  1. Maintain and implement new process improvements to the QMS system.
  2. Oversee quality release, labelling, complaints investigations, change control, NCRs, and CAPA.
  3. Manage local QC testing with external laboratories when required.
  4. Prepare the audit schedule and lead internal and external audits.
  5. Continuously maintain product registration and ensure compliance to regulatory requirements.
  6. Manage variation submissions, product registration renewal, and approval for any product changes.
  7. E nsure all labels and documents are up-to-date and comply with regulatory requirements.

Requirements

  • Tertiary University degree in a Scientific or Medical field.
  • Minimum 4 years of local QA/RA experience within the medical device or pharmaceutical industry.
  • Knowledge of ISO9001, GDP, and GMP.
  • Experience with QMS Systems and Microsoft Office.
  • Excellent verbal and written communication skills.
  • Ability to work autonomously, prioritize important tasks, and plan.

Benefits

  • 5 days on-site.
  • Opportunity to work within a global medical device organization.
  • Opportunity to collaborate with local and global stakeholders.
  • Competitive salary package.
  • Career progression opportunities.

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