Regulatory Affairs Strategic Leader

3 days ago

Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $180,000 - $240,000
Job Description

The Regulatory Affairs Strategic Lead is responsible for overseeing key regulatory activities to ensure compliance with relevant regulations and legislation.

Key Responsibilities
  • Provide strategic regulatory guidance on product registration pathways, regulatory strategies, and business acquisitions to support speed to market and alignment with commercial goals.
  • Identify and mitigate regulatory risks, ensuring compliance with legislation, standards, and corporate procedures while supporting post-market activities and change management.
  • Drive the implementation of new regulatory processes and contribute to continuous improvement initiatives that enhance compliance and operational efficiency.
  • Act as a key escalation point for complex regulatory issues, offering strategic solutions and collaborating across teams to resolve challenges effectively.
  • 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.
Benefits

The ideal candidate will have strong knowledge of medical device regulations in Australia and New Zealand, as well as international regulatory knowledge (e.g. FDA and EU MDR). Experience with Prostheses List management and team management is also desirable.

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