Regulatory Associate and Quality Associate

Job Listing No: 9740000

Regulatory Associate and Quality Associate

i-Pharm Consulting – Australia – JOB TITLE Regulatory and Quality Associate – Sydney Based JOB SUMMARY A Regulatory and Quality Associate is required for a small but growing medical devices company building their global operation from Sydney. The company has recently had a large capital injection globally providing an exciting phase in their growth. ROLE/DESCRIPTION Broad based Quality and Regulatory hybrid role supporting the manager Regulatory Submission to ANZ Product Listings Maintain Quality Management system in line with ISO13485, GMP, 21CFR820 and other standards relevant to the design, development, manufacture and distribution of a product. Document Control Configuration Management Provide oversight on CA/PA related activates REQUIREMENTS Life sciences degree (pharmacy preferred) Extensive experience in Australian Regulatory Affairs (and New Zealand ideally) Experience with TGA and Medsafe Reimbursement experience ISO 13485 knowledge People management would be a bonus Electroni… – Permanent – Full-time

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