Strategic Regulatory Solutions Expert

3 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $163,000 - $193,000
Key Regulatory Specialist Role

The primary objective of this position is to provide strategic support and guidance in the regulatory environment, encompassing all stages of product life cycles. Key deliverables include ensuring compliance and delivering optimal regulatory strategies for portfolio planning, active regulatory intelligence, and excellence in execution.

As a key member of the team, you will lead regulatory assessments, develop regulatory strategies, and collaborate with internal stakeholders and external regulators to achieve business goals.

  • Define regulatory strategies for products and services.
  • Author and review global regulatory submissions including FDA 510(K), CE MDR, TGA ARTG, and Health Canada dossiers for products.
  • Interpret device-specific requirements and translate them into clear, well-supported regulatory documentation.
  • Align closely with Regional Regulatory Affairs to ensure reusable, scalable submission approaches and consistent technical content.

This role requires the ability to manage a broad portfolio of products, including those that may not be medical devices in every market, and provide actionable strategies to support growth.

As a key point of contact, you will engage early in project scoping and risk management activities to shape regulatory deliverables and timelines.

Key responsibilities include mentoring junior team members in regulatory interpretation, submission content quality, and cross-functional collaboration, as well as contributing to process improvements and advocating best practices in tools like Jira, Confluence, and RIMSYS.

Successful candidates will have a strong knowledge of ISO 13485, ISO 14971, design control frameworks, and relevant market-specific regulations, as well as excellent communication, project planning, and cross-functional influence skills.

Required qualifications and experience include a Bachelor's degree in biomedical engineering, regulatory affairs, life sciences, or related discipline, 5+ years of experience in Regulatory Affairs within a regulated industry (preferably medical devices), and proven experience leading or coordinating global regulatory submissions.

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