Regulatory Affairs Specialist

2 days ago

Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $100,000 - $140,000
Senior Regulatory Affairs Specialist

This position offers the opportunity to lead regulatory assessments, develop strategic plans for product and service growth, and work closely with cross-functional teams to achieve business objectives.

The successful candidate will have a strong background in regulatory affairs, excellent communication skills, and the ability to manage multiple projects simultaneously. Experience working with medical devices, regulatory submissions, and submission platforms is highly desirable.

Key Responsibilities:
  • Develop and implement regulatory strategies for new and existing products.
  • Lead global regulatory submissions, including FDA 510(K), CE Marking, TGA ARTG, and Health Canada dossiers.
  • Mentor junior team members in regulatory interpretation and submission content quality.
  • Represent Regulatory Affairs in cross-functional design teams, ensuring regulatory compliance and effective communication.
Required Skills and Qualifications:
  • Bachelor's degree in biomedical engineering, regulatory affairs, life sciences, or related field.
  • 5+ years of experience in Regulatory Affairs within a regulated industry, preferably medical devices.
  • Strong knowledge of ISO 13485, ISO 14971, design control frameworks, and relevant market-specific regulations.
  • Excellent project planning, cross-functional influence, and communication skills.
About the Role:

You are a technical translator and regulatory expert who thrives in structured environments, applies high analytical rigor, and consistently delivers compliant, high-quality documentation. You are pragmatic and can bring people along, clarify complex concepts, and help organizations meet regulatory obligations while delivering innovation to market faster.

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