Regulatory Operations Specialist

Regulatory Operations Specialist role supporting medical device launches, site registrations, and global submissions at a surgical robotics company. The position involves preparing technical documentation, managing facility transfers, and developing regulatory tools and processes to enhance departmental efficiency.

Responsibilities

• Support new country product launches, global site registrations, and site renewals for multiple facilities
• Draft and maintain regulatory procedures, templates, SOPs, and process documentation
• Prepare standardized technical documentation for medical devices across global submissions
• Identify and implement process improvements based on data analysis and user feedback
• Collaborate with development teams on regulatory tools and workflow applications

Requirements

• 0-2 years relevant experience in medical device company or regulatory operations
• Bachelor's degree in science, engineering, or medical field; or Master's in Biomedical Engineering, Regulatory Science, or related discipline
• Strong attention to detail with ability to follow procedures and processes
• Proficiency in MS Word, Excel, and Outlook with capacity to learn additional software
• Written and oral communication skills with ability to work cross-functionally
• Ability to manage multiple tasks in fast-paced environment
• Data structure and algorithms knowledge; software design and architecture fundamentals