Sr Regulatory Operation Specialist

JOB DESCRIPTION

Job Title

Sr Regulatory Operation Specialist

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