Quality Assurance & Regulatory Affairs Specialist - Freelance, Remote

The Impact you’ll make

• Maintain and organize quality and regulatory files
• Oversee calibration and preventive maintenance programs
• Ensure implementation of corrective actions
• Monitor compliance with internal procedures

• Manage approval processes for SOPs, Forms, IFUs, and ECNs
• Control access to approved documents and literature
• Maintain documentation systems
• Review and approve product labeling
• Process Engineering Change Notices (ECNs)

• Support international regulatory submissions
• Prepare Certificates to Foreign Governments
• Ensure compliance with U.S., EU, and international requirements
• Monitor regulatory updates and changes

• Review product documentation for compliance
• Support quality system improvements
• Assist in implementation of corrective actions
• Maintain quality control processes

Skills, Knowledge and Expertise

• High School diploma (associate degree or higher preferred)
• Proficiency in Microsoft Office Suite
• Strong written and verbal communication skills
• Detail-oriented with analytical thinking capabilities
• Basic understanding of medical device regulations
• WFH Set-Up:
  • Computer with at least 8GB RAM, an Intel i5 core processor/AMD Ryzen 5 Processor and up.
  • Internet speed of at least 40MBPS
  • Headset with an extended mic that has noise cancellation and a webcam
  • Back-up computer and internet connection
  • Quiet, dedicated workspace at home

• Documentation management
• Quality control processes
• Regulatory compliance understanding
• Microsoft Office Suite expertise

• You thrive in structured, process-driven environments
• You have a passion for quality and compliance
• You enjoy detailed documentation work
• You're committed to maintaining high standards
• You're eager to learn about medical device regulations
• You're methodical and thorough in your work approach
• You have experience in FDA-regulated industries (a plus)
• You have familiarity with Engineering Change Notice (ECN) processes

• Remote position
• Must have a reliable internet connection and a quiet workspace
• Required to provide own computer with Intel Core i5 or something similar or higher operating system

• Monday to Friday, 9 AM to 5 PM EST (Eastern Standard Time)
• Occasional weekend availability for urgent matters
• 40 hours per week

• $7 per hour
• No benefits package included

Benefits