Regulatory and Quality Manager

An established Australian business operating within the regulated therapeutic goods sector is looking for an experienced Regulatory & Compliance Manager to take ownership of its regulatory compliance and quality documentation frameworks. This is a hands-on role with genuine scope to shape how compliance is managed across the organisation. You will work closely with senior leadership, operational teams and local and international suppliers to ensure product documentation, quality records and regulatory evidence are complete, defensible and audit-ready.  A key part of the position will be developing deep practical expertise in TGO 110, together with the relevant MDSO and Essential Principles requirements, and translating those obligations into processes that the wider business can actually use.

The Opportunity

You will become a key internal point of expertise for regulatory and quality matters, helping the business interpret changing requirements and turn them into clear actions.
Your remit will include reviewing the existing product portfolio for compliance gaps, strengthening technical files and evidence packs, improving the QMS and document-control environment, and building more robust regulatory registers, workflows and change-control processes.
You will also provide regulatory input into new product development, support supplier documentation and quality requirements, assist with audit readiness and engage with the TGA where required.

What you'll be responsible for

• Developing practical regulatory frameworks, checklists, SOPs and guidance around TGO 110 and related requirements
• Reviewing products and supporting evidence to identify compliance gaps, risks and remediation priorities
• Strengthening the QMS, document control, traceability, change control and quality records
• Maintaining audit-ready technical files, evidence packs, registers and compliance databases
• Supporting CAPAs, internal audits and continuous improvement activities
• Working with local and international suppliers to obtain and maintain technical and quality documentation
• Building structured supplier documentation and quality expectations
• Providing regulatory and compliance input into product development and product changes
• Monitoring regulatory developments and translating emerging requirements into practical business actions
• Providing management with clear visibility of compliance status, risks, priorities and upcoming requirements

What we're looking for
You will bring demonstrated regulatory and/or quality compliance experience from a regulated healthcare environment, such as pharmaceuticals, therapeutic goods, medical devices or a closely aligned sector.  You'll be confident interpreting regulatory requirements and standards and turning them into practical, fit-for-purpose systems and processes.
Strong experience in QMS development and documentation control is important, as is a disciplined approach to record keeping, version control and evidence management.
This role will suit someone who is comfortable working autonomously, can manage competing priorities and knows how to drive outcomes across technical, operational and senior stakeholders.
Experience with medical devices, MDSO, Essential Principles, audit readiness, unregistered products, pharmaceutical supply chains or international manufacturers and suppliers would be highly regarded. A degree in Pharmacy, Science or a related discipline, or equivalent relevant experience, is preferred.

Why consider this role?
This isn't a position where you'll simply maintain an established compliance system. You'll have the opportunity to improve the regulatory framework, strengthen the organisation's quality systems and build practical compliance processes that influence products across their lifecycle.  For someone who enjoys interpreting complex requirements, creating order from technical information and becoming the trusted regulatory authority inside a business, there is substantial scope to make an impact.

For further information on regarding this role - please contact Jo Turner, Divisional Manager jturner@hpgconnect.com