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The primary role of the Regulatory Affairs function is to provide strategic support and guidance with respect to regulatory environments at all stages of product life cycles.
Position Responsibilities- Develop regulatory strategies for products led by the Incubation and Growth team.
- Author and review global regulatory submissions including FDA 510(K), CE MDR, TGA ARTG, and Health Canada dossiers for ResMed products.
- Interpret device-specific requirements and translate them into clear regulatory documentation.
- Collaborate with Regional Regulatory Affairs teams to ensure consistent technical content.
- Lead assessments of design and process changes, performing significance evaluations and preparing documentation updates.
- 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.
