Quality And Regulatory Analyst 2

Australasian Medical and Scientific Limited

Unknown, Unknown, Unknown
Not specified
Iso 9001:2015 compliant qms development
Good wholesaling practice gwp knowledge
Medsafe and tga registration processes
Australasian Medical and Scientific Limited (AMSL) is seeking a Quality and Regulatory Analyst with experience in ISO 9001:2015-compliant Quality Management Systems and knowledge of medical device registration processes. The ideal candidate will possess strong analytical skills, attention to detail, and excellent communication abilities, contributing to compliance and quality improvement in diabetes care products

Job Summary

  • The role involves coordinating tasks related to the Quality Management System to ensure compliance with principal company requirements and regulatory frameworks.
  • You will manage all aspects of pharmacovigilance and device vigilance activities, ensuring timely reporting and adherence to applicable codes.
  • The position supports the preparation and submission of regulatory documentation to obtain and maintain product registrations in Australia and New Zealand.

Matching Summary

Match Score: 85

Australasian Medical and Scientific Limited (AMSL) is seeking a Quality and Regulatory Analyst with experience in ISO 9001:2015-compliant Quality Management Systems and knowledge of medical device registration processes. The ideal candidate will possess strong analytical skills, attention to detail, and excellent communication abilities, contributing to compliance and quality improvement in diabetes care products.

Skills & Requirements

Must-have

  • ISO 9001:2015 compliant QMS development
  • Good Wholesaling Practice GWP knowledge
  • Medsafe and TGA registration processes
  • Pharmacovigilance and device vigilance management
  • Internal and external audit execution

Nice-to-have

  • Strong analytical thinking skills
  • Excellent written and verbal communication
  • Cross-functional collaboration abilities
  • High attention to detail
  • Microsoft Office Suite proficiency

Key Requirements

  • Bachelor's degree required
  • 2-5 years of related experience
  • Knowledge of Medsafe and TGA processes

Work Rights

Not specified

Tailored Resume

Cover Letter