- Full Time, 12 month contract
- Hybrid working conditions
- Be at the forefront of personalized healthcare and biotechnology
About the Company
Our client is a world-leading global healthcare and diagnostics innovator dedicated to transforming lives through cutting-edge medical technologies. With a strong focus on scientific excellence and patient outcomes, they provide a collaborative, dynamic, and forward-thinking environment. They are currently seeking a meticulous and driven Regulatory Affairs and Quality Associate to join their high-performing compliance team.
Role Purpose
In this pivotal role, you will be responsible for supporting both regulatory and quality compliance across a premium portfolio of products. Working across both local and global networks, you will ensure seamless market access and strict adherence to Australian medical compliance standards.
Key Responsibilities
- Prepare, format, and submit high-quality registration dossiers for product approvals and variations to the Therapeutic Goods Administration (TGA).
- Monitor compliance with TGA regulations, manage product recall processes, and coordinate the submission of Medical Device Incident Reports.
- Support the standardisation, implementation, and maintenance of local quality management systems aligned with global frameworks and standards.
- Actively participate in internal audit programs and assist in preparing for and supporting external regulatory and global quality audits.
- Act as a key liaison between cross-functional local teams and global quality networks to assess the business impact of product and regulatory changes.
Skills & Experience Required
- An undergraduate degree in Science or a related equivalent discipline.
- Demonstrated knowledge of the Australian regulatory environment specifically for IVDs or Medical Devices.
- A solid understanding of ISO 9001 and ISO 13485 standards, as well as the Therapeutic Goods Act 1989.
- Familiarity with Medical Device Vigilance reporting requirements and relevant Industry Codes of Practice.
- Exceptional analytical and problem-solving skills, strong attention to detail, and the ability to effectively communicate complex technical details to diverse stakeholder groups.
What’s on Offer
- An opportunity to work with a prestigious, global leader in the healthcare space.
- A dynamic role bridging both corporate strategy and technical compliance.
- A collaborative culture that actively fosters professional development and continuous improvement.
To Apply
If you are a compliance professional looking to advance your career with an industry champion, please click "Apply Now" to submit your resume and cover letter.
At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.
