Regulatory Affairs Expert
4 days ago
The role encompasses supporting and guiding the company in its interactions with regulatory bodies, throughout the product life cycle.
Key Responsibilities:- Develop strategic plans for incubation and growth products to ensure compliance with regulatory requirements.
- 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 (e.g., ISO 13485, ISO 14971) and translate them into clear, well-supported regulatory documentation.
- Collaborate with cross-functional teams to resolve submission blockers and maintain lifecycle documentation compliance.
- Expertise in regulatory affairs and strong knowledge of global regulations.
- Strong analytical and problem-solving skills, with ability to interpret complex regulatory information.
- Excellent communication and collaboration skills, with ability to work effectively with cross-functional teams.
Opportunity to work in a dynamic and innovative environment, with access to cutting-edge technology and resources.
Others:Responsible for maintaining accurate and up-to-date regulatory documentation.
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