Senior Regulatory Affairs (RA) Specialist

About the role

Regulatory Affairs Specialist will support the development and execution of global regulatory strategies for medical devices and combination products. role is responsible for preparing regulatory submissions, maintaining product registrations, supporting product lifecycle activities, and ensuring compliance

What you'll do

• Support the development and
• Implementation of regulatory strategies for medical devices and
• Combination products across global markets
• Prepare, compile, review, and
• Maintain regulatory submissions including FDA 510(k), PMA, De Novo, EU MDR

What you need

• 5–9 yrs of experience
• Regulatory affairs
• Documentation
• Technical writing
• Internal audit
• Communication
• Any graduate