Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist prepares, submits, and maintains regulatory submissions and lifecycle documentation for medical devices, including FDA 510(k) submissions and IVDR Class C recertifications. This role serves as a subject matter expert, guiding design control activities, new product development teams, and cross-functional stakeholders on regulatory compliance and quality guidelines. The position involves leading regulatory projects, reviewing promotional materials, and ensuring audit-ready documentation while collaborating with internal and external auditors.