Regulatory Affairs Expert

1 day ago

Sydney, New South Wales, Australia beBeeTechnical Full time $150,000 - $200,000

About Us

Our team leads regulatory strategy and delivery for products, including masks, CPAP devices, ventilators, and accessories. We support both new product introduction and product lifecycle engineering across high-volume, global portfolios.

As an individual contributor in this team, you will partner with cross-functional teams and global stakeholders to drive submission readiness, change assessments, and technical documentation that meet diverse market requirements.

Key Responsibilities:

  • Author and review regulatory submissions, including FDA 510(k), CE MDR, TGA ARTG, and Health Canada dossiers for masks, CPAP devices, and ventilators.
  • Interpret device-specific requirements and translate them into clear, well-supported regulatory documentation.
  • Align closely with Regional teams to ensure reusable, scalable submission approaches and consistent technical content.

Cross-Functional Integration & Design Control Support:

  • You will represent Regulatory Affairs in cross-functional design teams for our products.
  • Engage early in project scoping and risk management activities to shape regulatory deliverables and timelines.
  • Act as a key point of contact for internal stakeholders on our product regulatory requirements and interpretations.

Mentorship & Peer Enablement:

  • Mentor junior team members in regulatory interpretation, submission content quality, and cross-functional collaboration.
  • Support onboarding and documentation standardization across the team.
  • Contribute to process improvements and advocate best practices in tools like Jira and Confluence.

Qualifications & Experience:

  • 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).
  • Proven experience leading or coordinating global regulatory submissions.
  • Strong knowledge of ISO 13485, ISO 14971, design control frameworks, and relevant market-specific regulations.
  • Excellent communication, project planning, and cross-functional influence skills.

Who You Are:

You are a technical translator and regulatory mentor—someone who thrives in structured environments, applies high analytical rigor, and consistently delivers compliant, high-quality documentation. You bring people with you, clarify the complex, and help us meet regulatory obligations while getting innovation to market faster.

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