Senior Regulatory Affairs Specialist - Medical Devices

Boston Scientific seeks a Senior Regulatory Affairs Specialist to lead regulatory submissions and maintain ongoing compliance for Class II and III medical devices across multiple sites including Ireland and the US. You will plan strategies, manage cross-functional projects, and coordinate PMAs, 510(k)s, and CE MDR submissions.

The role requires 4+ years in regulatory affairs for medical devices, strong technical writing, and deep knowledge of US FDA and EU MDR regulations.