Quality And Regulatory Manager

1 week ago

Sydney, New South Wales, Australia Healthdirect Australia Full time

Work at the forefront of virtual health service delivery in Australia
- Influence company-wide quality strategy and implementation.
- 2 year fixed-term contract

**About us**

At Healthdirect Australia we work with purpose and dedication to help Australians actively manage and improve their health.

Our virtual services are easily accessible via multiple channels, including helplines, video call solutions and websites and cater for Australians at all stages of life. No matter where people live, or what time of the day or night it is, they can use our services to talk to a health professional, find trusted information and advice online and locate their closest health service.

**About the opportunity**

We're seeking an exceptional Quality and Regulatory Manager to lead our compliance initiatives and establish a robust Quality Management System from the ground up. This critical position will ensure our adherence to TGA regulations, ISO 13485 standards, and Australian Therapeutic Goods (Medical Devices) Regulations 2002.

You'll drive continuous improvement while maintaining essential certifications and collaborate across all business units to implement efficient, effective quality processes.

Key Responsibilities:

- Build a comprehensive QMS aligned with TGA regulatory requirements
- Drive quality improvement initiatives throughout the organisation
- Secure and maintain all necessary quality and product certifications
- Facilitate cross-departmental collaboration to streamline quality processes
- Conduct Management Review meetings and oversee regulatory reporting
- Manage post-market surveillance activities and production corrections
- Provide regular QMS performance updates to the Chief Corporate Services Officer
- Deliver expert guidance on quality management across all projects and initiatives

**You can contribute through your**:

- 5+ years quality management experience in software medical devices
- Advanced knowledge of ISO 13485, ISO 14971 and IEC62304 standards
- Proven experience implementing a QMS from ground up
- Internal audit and CAPA management experience
- Demonstrated ability to influence stakeholders and lead change
- Excellent leadership and communication

**Why work with us**

We believe our strength comes from our talented and dedicated staff. We are committed to working together to create a culture where you can bring your whole self to work.

Our benefits include:

- Flexible work arrangements.
- 14 weeks company Paid Parental Leave for both parents.
- Multi-dimensional wellbeing program that is run by our people for our people.
- Individual curated learner journeys to support you to expand your capabilities and unlock your talent.

To find out more about Healthdirect, and our vision for a healthier Australia, please visit our website - about.healthdirect.gov.au

As an Equal Opportunity Employer, we respect and seek to empower each individual and support the diverse cultures, perspectives, skills, and experiences within our workforce.

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