BD13 jobs

Regulatory & Quality Business Partner

Mid levelFull-timeOfficeNorth Ryde NSW 2113, AustraliaPosted 4 days agoVerified 5 days ago
Pending fitX of Y criteria met

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.

Meet the team

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You'll be responsible for

🤝

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

📜

Regulatory affairs experience

Demonstrated experience in Regulatory Affairs within MedTech.

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🔍

Quality management system knowledge

Experience working within a Quality Management System, e.g., ISO 13485.

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🌏

Understanding of ANZ regulations

Strong understanding of medical device regulations in Australia and New Zealand.

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A meaningful career starts with a match

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5 criteria for this job
Regulatory affairs experience
Demonstrated experience in Regulatory Affairs within MedTech.

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Quality management system knowledge
Experience working within a Quality Management System, e.g., ISO 13485.

View

Understanding of ANZ regulations
Strong understanding of medical device regulations in Australia and New Zealand.

View

Stakeholder engagement skills
Proven ability to influence and partner with commercial stakeholders.

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Analytical skills
Strong analytical skills with attention to detail in compliance matters.

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