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Senior Regulatory Affairs Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $150,000
Job Description:
As a Senior Regulatory Affairs Specialist, you will play a critical role in leading regulatory strategy and execution for ResMed's core portfolio of Sydney-manufactured devices. You will be responsible for authoring and reviewing global regulatory submissions, including FDA 510(k), CE MDR, TGA ARTG, and Health Canada dossiers.

Key Responsibilities:
- Author and review global regulatory submissions, including device-specific requirements and technical documentation.
- Interpret device-specific requirements and translate them into clear, well-supported regulatory documentation.
- Align closely with Regional RA to ensure reusable, scalable submission approaches and consistent technical content.

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 (e.g., 510(k), CE Marking, TGA ARTG).
- Strong knowledge of ISO 13485, ISO 14971, design control frameworks, and relevant market-specific regulations.
- Excellent communication, project planning, and cross-functional influence skills.

Benefits:
ResMed is a company that creates life-changing health technologies. We're committed to pioneering innovative technology to empower millions of people in more than 140 countries to live happier, healthier lives. Our AI-powered digital health solutions, cloud-connected devices, and intelligent software make home healthcare more personalized, accessible, and effective.