Regulatory Affairs Expert

3 days ago

Sydney, New South Wales, Australia beBeeRegulatoryAffairsLead Full time $200,000 - $250,000
Regulatory Affairs Lead Job Description

The Regulatory Affairs Lead plays a pivotal role in ensuring compliance with regulatory requirements and driving key activities for the organization.

Job Responsibilities:
  • Strategic Guidance: Provide expert advice on product registration pathways, regulatory strategies, and business acquisitions to support speed to market and alignment with commercial goals.
  • Risk Management: Identify and mitigate regulatory risks, ensuring compliance with legislation, standards, and corporate procedures while supporting post-market activities and change management.
  • Process Improvement: Drive the implementation of new regulatory processes and contribute to continuous improvement initiatives that enhance compliance and operational efficiency.
  • Stakeholder Engagement: Act as a key escalation point for complex regulatory issues, offering strategic solutions and collaborating across teams to resolve challenges effectively.
  • Leadership Development: Mentor and coach team members, fostering growth and building technical competency to strengthen regulatory expertise across the team.
Requirements:
  • A minimum of 8 years' experience within a Regulatory Affairs, Quality, or similar field and demonstrable success in analysis and interpretation of regulatory documentation and technical writing.
  • Tertiary qualifications in a technical discipline (e.g., Science, Engineering, or related).
  • Strong communication, negotiation, and influencing skills – the ability to quickly build meaningful relationships with internal teams, external stakeholders, and government departments.
  • A self-driven, strategic thinker who can balance attention to detail and quality with the ability to thrive in a fast-paced environment and high-performance organization.
Preferred Qualifications:
  • 5+ years of experience in Medical Device regulatory affairs, with a solid understanding of both Australian and international regulatory environments.
  • Strong knowledge of the medical device regulations in Australia and New Zealand. International regulatory knowledge also a plus (e.g., FDA and EU MDR).
  • Experience with Prostheses List management.
  • Team management experience.
Why Join Our Team?

This is an opportunity to join a dynamic organization that values innovation, collaboration, and professional development. As a Regulatory Affairs Lead, you will play a critical role in shaping our regulatory strategy and contributing to the company's mission to make healthcare better.

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