Global Regulatory Affairs Operations Specialist

Edwards Lifesciences; California (MO); On-site; USD 59,000 - 83,000; Full time

Job summary

Edwards Lifesciences is seeking an Associate Specialist in Regulatory Affairs Operations TMTT in California to contribute to global regulatory submissions and publications. You will coordinate deliverables, maintain regulatory records, and support audits, ensuring compliance across Class I–III devices.

This role emphasizes cross-functional collaboration, attention to detail, and expertise in regulatory requirements for medical devices.

Qualifications

• Bachelor's Degree or equivalent work experience based on Edwards criteria.
• Coursework, seminars, and/or other formal government and/or trade association training or equivalent work experience based on Edwards criteria.
• Experience in a regulated industry and strong written/verbal communication are preferred.

Responsibilities

• Develop routine Regulatory Affairs process improvement initiatives including system enhancements, training reports, and/or dashboards
• Execute the coordination of submissions deliverables, schedule and tracking of appendices and documents
• Prepare compilation and publication of paper and electronic documentation packages for submission to global regulatory agencies in collaboration with team members
• Support management, retrieval, archival, and maintenance of regulatory records and submission documentation in accordance with applicable procedures and regulatory requirements
• Maintain regulatory systems, databases, and tracking tools to ensure accuracy, completeness, and data integrity of regulatory information
• Review and/or interpret standard assessments to ensure product compliance
• Interact effectively within the regulatory affairs team in the preparation of documentation packages, supporting team and company goals and objectives
• Prepare for regulatory agency inspections and audits (e.g., track RA plans and changes, understanding requirements)

Skills

Attention to detail

Project management

Communication skills

Education

Bachelor's degree or equivalent

Tools

Microsoft Office Suite

Job description

Edwards Lifesciences is seeking an Associate Specialist in Regulatory Affairs Operations TMTT in California to contribute to global regulatory submissions and publications. You will coordinate deliverables, maintain regulatory records, and support audits, ensuring compliance across Class I–III devices.

This role emphasizes cross-functional collaboration, attention to detail, and expertise in regulatory requirements for medical devices.