• QARA Manager Australia
  • Brunel in Australia, , Australia
  • jobs
  • 1 week ago

jobs description

Key Responsibilities:
• Develop and implement quality management systems (QMS) for digital health products and services, ensuring adherence to applicable regulatory requirements (e.g., FDA, ISO, HIPAA, GDPR).
• Collaborate cross-functionally with product development, engineering, regulatory affairs, and other teams to integrate quality and regulatory considerations throughout the product lifecycle.
• Conduct risk assessments and establish risk management processes to identify and mitigate potential hazards associated with digital health technologies.
• Lead regulatory submissions and registrations for new product launches, updates, and modifications, including premarket notifications, 510(k) submissions, CE marking, and other regulatory filings as required.
• Conduct internal audits and assessments to evaluate the effectiveness of quality systems and processes, and drive continuous improvement initiatives based on findings and feedback.
• Serve as the primary point of contact for... regulatory agencies, notified bodies, and other external stakeholders regarding quality and regulatory matters, representing the company with professionalism and expertise.
• Provide guidance and support to cross-functional teams during regulatory inspections, audits, and inquiries, ensuring readiness and compliance with regulatory expectations.
• Collaborate with external partners, consultants, and vendors to address quality and regulatory challenges and leverage external expertise as needed.

• Bachelor's degree in a relevant field (e.g., engineering, life sciences, regulatory affairs); advanced degree or certification (e.g., RAC) preferred.
• years of experience in quality assurance, regulatory affairs, or a related function within the medical device, pharmaceutical, or digital health industry.
• Demonstrated expertise in interpreting and applying regulatory requirements and standards applicable to digital health products and software (e.g., FDA regulations, ISO 13485, IEC 62304, HIPAA, GDPR).
• Proven track record of leading successful regulatory submissions and managing interactions with regulatory agencies and notified bodies


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