Headquartered within Sydney Australia, AusDiagnostics is a local primary manufacturer of a range of molecular diagnostic instrumentation and reagents for use within human, veterinary and food diagnostics. AusDiagnostics have direct sales & operations throughout the globe.

Main Duties/Responsibilities 

The primary objective of this role is to:

• Assist with all product registrations processes globally
• Drive compliance for all regulation requirements throughout the organization
• Advise on regulatory pathways and strategies for product submissions
• Conduct regular internal and external analysis to ensure adherence to all global regulatory directives for legal supply of IVD products
• Manage document control and approval processes for all QA/RA documentation, including SOPs
• Collect, collate and evaluate scientific data
• Conduct QMS training
• Achieve corporate quality objectives of the business
• Build productive collaborative interactions with all stakeholders within the business
• Manage product compliance and non-conformance reporting functions
• Support in R&D product translation to commercialization
• Manage customer advisory notification process
• Regulatory liaison for international matters relating to product file compliance /labelling
• Support in external audit preparations
• Conduct regular scheduled internal audits to ensure compliance to accreditation standards

Qualifications

Minimum Bachelor's Degree in related field

Desired Experience

• 3 years previous experience in a similar role/industry
• Previous experience in Regulatory Affairs in Medical Devices or IVD industry
• Previous work experience in RA supporting function within IVD Manufacturing
• ISO 13485 Compliance Experience

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