Qara Specialist

6 days ago

Sydney, New South Wales, Australia Ke Select Full time

Prestigious manufacturer of laboratory-based clinical diagnostic instruments
- QARA role for laboratory-base clinical diagnostics instruments
- Work with an international QARA team, hybrid work arrangement offered.

**About the Company**
A renowned global manufacturer of laboratory-based diagnostic equipment, with more than 70 years on the forefront of clinical diagnostics; Our client offers a comprehensive range of cutting-edge diagnostic instruments, assays, and informatics systems that enable medical scientists to diagnose and monitor diseases efficiently and accurately.

**About the Role**
As an integral part of the QARA department at Lower North Shore of Sydney, you will have the opportunity to work in a hybrid position. Reporting to the Quality & Regulatory Affairs Manager ANZ, you will be working in an international, matrix environment and contribute to building a world-class QARA team.

Your key responsibilities will include:

- Managing and leading internal audits for ANZ, adhering to ISO 13485 and ISO 9001 standards.
- Assisting in the preparation of documentation for product registration, tenders, change notifications, and more.
- Assisting with post-market reporting obligations in ANZ, including recall actions and adverse event reporting to regulatory bodies like the TGA and Medsafe.
- Keeping abreast of relevant regulatory and legal changes and effectively communicating updates to stakeholders.
- Addressing quality or regulatory inquiries from local, regional, and global stakeholders.

**About You**
This role is ideal for experienced QARA professionals, ideally with an IVD/medical background

To qualify for this position, you should have the following essential requirements:

- A bachelor's degree in a Scientific or Medical field.
- A minimum of 5 years of experience in the medical device, in-vitro diagnostic medical device, or pharmaceutical industries in a technical capacity.
- Experience in implementing ISO 13485 and/or ISO 9001.
- Familiarity with the regulation of TGA.
- Demonstrated ability to independently lead projects involving multiple stakeholders.

KE Select are a leading provider of Scientific, Medical and Technical recruitment services.

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