About the job
This job is about shaping regulatory and quality outcomes for a newly integrated portfolio across Australia and New Zealand. As a Regulatory & Quality Business Partner at BD, you will play a vital role in ensuring compliance while enabling business growth. The team thrives on collaboration, working closely with commercial leaders and global stakeholders to embed regulatory and quality requirements throughout the product lifecycle.
You'll be responsible for
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Partnering with commercial and functional leaders
Providing practical regulatory and quality guidance to ensure compliance is integrated into business decisions.📄
Managing regulatory submissions and product registrations
Overseeing the lifecycle maintenance with TGA, Medsafe and other authorities to ensure compliance.📦
Supporting post-market activities
Handling complaints, adverse events, field actions, and recalls to maintain product quality and safety.Key criteria
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Regulatory affairs experience
Demonstrated experience in Regulatory Affairs within MedTech.View
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Quality management system knowledge
Experience working within a Quality Management System, e.g., ISO 13485.View
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Understanding of ANZ regulations
Strong understanding of medical device regulations in Australia and New Zealand.View
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