Sr. Regulatory Affairs Operations Specialist

Responsible for leading process improvement efforts across the Regulatory Affairs department, managing medical device standards and regulations, and ensuring compliance with applicable state, federal, and international regulations.

Requirements

• Serve on business and department projects for process/system updates and implementations.
• Assess existing processes within regulatory affairs to identify opportunities for improvement.
• Create strategies and implement solutions to improve the quality and efficiency of regulatory tasks.
• Serve as Regulatory Affairs SME for system requirements and responsible for maintenance of applicable systems to support regulatory activities.
• Ensure compliance with regulations pertaining to site establishment registrations, certificates, and licensing.
• Support global monitoring, assessment, and communication of evolving medical device regulations and standards, maintaining accurate standards databases and ensuring timely impact evaluation across product, QMS, and documentation processes.
• Coordinate cross-functional implementation of new or updated standards by partnering with RA, Quality, R&D, and Operations to maintain audit-ready compliance records, drive documentation updates, and support readiness for notified body and internal audits.
• Maintain regulatory files and records.
• Responsible for establishing regulatory procedures and processes as needed, initiating updates as necessary in a regulated environment.
• Build team cohesiveness by influencing and supporting team members.
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.

Benefits

• Comprehensive health insurance
• 401(k) matching
• Paid time off
• Retirement plan
• Education assistance