Regulatory Compliance Associate

3 weeks ago

Macquarie Park, Australia Randstad Full time

Role Summary: We are seeking a skilled Regulatory Affairs and Quality Associate to support 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.

Requirements:

  • 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.

About the Role: 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.

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