Expert Regulatory Affairs Specialist

8 hours ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $180,000 - $250,000

Regulatory Affairs Expert

Job Summary:

The Regulatory Affairs Lead oversees key regulatory activities, ensuring compliance and strategic alignment. This role bridges operational and strategic functions, driving regulatory excellence and team development.

Key Responsibilities:

  • Strategic Regulatory Guidance: Provide expert advice on product registration pathways, regulatory strategies, and business acquisitions to support speed to market and commercial goals;
  • Risk Management and Compliance: Identify and mitigate regulatory risks, ensuring compliance with legislation, standards, and corporate procedures while supporting post-market activities and change management;
  • Process Improvement and Implementation: Drive the implementation of new regulatory processes and contribute to continuous improvement initiatives that enhance compliance and operational efficiency;
  • Stakeholder Engagement and Issue Resolution: Act as a key escalation point for complex regulatory issues, offering strategic solutions and collaborating across teams to resolve challenges effectively; and
  • Leadership and Team 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; and
  • 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;
  • 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.

Benefits:

This role offers opportunities for professional growth and development in a dynamic organization.

The company impacts more than 150 million patients annually, providing innovative products and services in MedSurg, Neurotechnology, and Orthopaedics.

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