Regulatory Affairs Specialist

Job Summary

Regulatory Affairs Specialist is a full-time position responsible for collecting documentation for regulatory submissions, communicating with stakeholders, and supporting compliance activities in a regulated industry.

Key Responsibilities

• Collect and prepare documentation for regulatory submissions and agency approvals
• Maintain regulatory files and track submission processes to ensure timely compliance
• Support internal and third-party audits and participate in special projects as needed

Required Qualifications

• Bachelor's Degree in a Scientific/Engineering discipline or equivalent experience in a regulated industry
• Understanding of FDA 21CFR Part 820 QMSR, EU MDR, MDSAP, CMDR, and ISO 13485
• Proficient in computer skills, including Adobe Professional and MS Office applications
• Ability to manage multiple projects in a fast-paced environment
• Working knowledge of ISO Standards as special controls