Regulatory Affairs and Quality Associate
- Global medical devices company
- Local manufacturing
- Great company culture
An exciting opportunity is available for a skilled Regulatory Affairs and Quality Associate to join a dynamic team in Australia. This role involves supporting regulatory and quality compliance for a portfolio of products within the medical devices sector.
Key Responsibilities:
- Prepare and submit applications for product registration and modifications in alignment with business strategies.
- Stay informed on regulatory changes, assess their impact, and support audits and recalls.
- Collaborate with internal stakeholders and external regulatory bodies to ensure compliance.
- Maintain up-to-date knowledge of medical devices ISO 9001, ISO 13485: 2016 standards, the Therapeutic Goods Act 1989, and relevant Federal and State regulations. Contribute to the development, implementation, and optimization of quality management systems and processes.
- Engage in product vigilance activities, including reporting incidents & submissions to the Therapeutic Goods Administration (TGA).
- Support and participate in the internal audit program, ensuring adherence to global modular Quality Management System (mQMS) processes.
What We're Looking For:
- Undergraduate degree in Science or equivalent.
- Relevant experience with the Australian regulatory environment for medical devices.
- Strong understanding of Quality Management Systems (ISO 9001 and ISO 13485).
- Knowledge of Medical Device Vigilance reporting, industry standards, and guidelines.
- Strong experience in managing Australia regulatory, TGA, submissions and requirements.
- Strong knowledge of the TGA Advertising Code for medical devices
- Strategic thinker with strong analytical skills, attention to detail, and the ability to manage multiple projects.
- Excellent written and verbal communication skills, capable of conveying complex regulatory information effectively.
- Ability to collaborate across cross-functional teams and present key considerations effectively.
Why Join Us? This role offers a unique opportunity to work across a broad network, both within the company and globally, contributing to the success of products that make a real difference in healthcare. You'll be part of a forward-thinking team that values compliance, continuous improvement, and strategic thinking.
If you are passionate about regulatory affairs and quality management and are eager to make an impact in the medical devices and diagnostics field, we encourage you to apply.
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.
...
