Regulatory Standards Management (RSM) Specialist - Remote

Overview

We are seeking a detail-oriented Regulatory Standards Management (RSM) Specialist to support compliance activities by monitoring and integrating global standards and regulations. You will work closely with cross-functional teams to track Regulatory Surveillance Assessments (RSAs), maintain accurate documentation, and ensure timely execution of regulatory processes.

In Short

• Review and track RSAs and Regulatory Surveillance Records (RSRs)
• Coordinate with Subject Matter Experts (SMEs) and Regulatory Affairs (RA)
• Maintain process logs and generate reports
• Support audit readiness and quality system processes
• Manage standards and documentation via Agile PLM and TrackWise

Requirements

• Bachelor's degree or equivalent experience
• Familiarity with ISO 9001/13485 and quality systems
• Proficiency in MS Office, TrackWise, Agile PLM, and Smartsheet
• Strong organizational, communication, and project management skills

Benefits

• Comprehensive benefits package