Regulatory Affairs Specialist

5 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $120,000

Key Responsibilities

The successful Regulatory Affairs Associate will play a vital role in supporting on-market activities across various divisions. This is an exciting opportunity to work collaboratively with cross-functional teams and contribute to the development of regulatory strategies that drive business growth.

This role involves preparing and lodging regulatory submissions, including those requiring conformity assessments, for changes to on-market in vitro diagnostic (IVD) products and updates to internal compliance records. The candidate will review and evaluate the scientific integrity of submission documents to ensure alignment with regulatory standards before forwarding them to the appropriate national authority.

Main Aspects Of This Role Include:

  • Developing and implementing regulatory strategies that support on-market products
  • Preparing and lodging regulatory submissions, including those requiring conformity assessments
  • Reviewing and evaluating the scientific integrity of submission documents
  • Providing advice on local compliance needs to support innovation product maintenance requirements and/or modifications
  • Partnering with marketing to review and approve promotional content, ensuring adherence to local advertising regulations
  • Mentoring and training regulatory affairs colleagues, while leveraging data to identify and implement process improvements
  • Staying up-to-date with emerging regulations and communicating potential impacts to both local and global teams
  • Driving process updates in response to such changes, collaborating with Quality Assurance to ensure integration into the quality management system
  • Sourcing additional regulatory authorisations as needed, such as import permits and Certificates of Free Sale (CFS)
  • Providing timely regulatory intelligence and updates to leadership and cross-functional teams
  • Maintaining accurate regulatory documentation and records in accordance with internal procedures and regulatory requirements
  • Ensuring all regulatory decisions and activities are accurately documented
  • Prepared regulatory reports and summaries for internal and external stakeholders
  • Participating in cross-functional projects to meet regulatory and quality goals

Requirements

  • A degree in science, biomedical studies, or a related field
  • At least 2–3 years of experience in regulatory affairs within the medical device or IVD sector
  • Solid understanding of both Australian and international regulatory frameworks (e.g., TGA, FDA, EU IVDR)
  • Familiarity with ISO 13485 and other relevant quality standards
  • Exceptional verbal, written, and interpersonal communication skills
  • Ability to work autonomously and collaboratively in a dynamic environment
  • Exceptional attention to detail across all regulatory and quality tasks
  • A mindset geared toward innovation and continuous improvement
  • Proactive engagement with industry trends and regulatory updates
  • Proven ability to manage multiple projects and competing priorities
  • Proficiency in Microsoft Office and other standard business applications

What We Offer

  • A collaborative team culture that values open communication, diversity, and shared learning
  • Ongoing opportunities for professional development and growth
  • Competitive salary and benefits package

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