Sr Regulatory Operation Specialist

**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**
+ **Lead and support international regulatory submissions for SaMD and medical device products (US, EU, Canada, and other global markets)**
+ **Support regulatory strategy development for product lifecycle activities, including new registrations,...