Medical Devices Regulatory Specialist
6 hours ago
Regulatory Affairs Specialist Overview
This role leads regulatory strategy and submission execution for all physical products where the legal manufacturer is involved—including masks, CPAP platforms, life-support ventilators, and accessories.
Key Responsibilities:- Autorize and review global regulatory submissions including FDA 510(k), CE MDR, TGA ARTG, and Health Canada dossiers for masks, CPAP devices, and ventilators.
- Interpret device-specific requirements (e.g., ISO 17510, ISO 80601, ISO 18562) and translate them into clear, well-supported regulatory documentation.
- Align closely with Regional RA to ensure reusable, scalable submission approaches and consistent technical content.
- 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.
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