**Senior Regulatory Affairs Specialist**
**In this role you**
The Senior Regulatory Specialist will work within our Sleep & Respiratory Care business group (SRC) on home and hospital respiratory care products. This may include ventilators, oxygenators, and other accessories. The role will provide day-to-day regulatory support for new product development and sustaining activities including but not limited to change order support, regulatory planning, and other activities as directed by management.
**Your role:**
+ The Senior Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW
+ Collaborate with the cross functional team (including R&D, design quality, marketing, supply chain etc.) to create submission contents.
+ Lead 510(k) submission, preparation of EU MDR Technical Documentation, Health Canada license applications and other global registrations and work wit...