Sr Regulatory Operation Specialist

Job Title

Job Description

Job Summary

We are seeking an experienced Senior Regulatory Affairs Operation Specialist with deep expertise in Software as a Medical Device (SaMD) to lead and support global regulatory activities. This role is responsible for driving international product registrations, managing regulatory databases, ensuring compliance with global standards, and supporting end-to-end submission strategies for software-driven medical technologies.

The ideal candidate will have strong knowledge of global regulatory frameworks, SaMD standards, and proven experience managing complex regulatory submissions across multiple geographies.

Job Title: Sr Regulatory Operation Specialist

Key Responsibilities

Regulatory Strategy & Submissions