Quality Assurance & Regulatory Affairs Specialist - Freelance, Remote

Quality Assurance & Regulatory Affairs Specialist -

Freelance, Remote Department:

Specialized Roles Employment Type:

Full Time Location:

Global+

Reporting To:

Client via

Magic Compensation:

$7.00 / hour Description About the Client Our client is a leading medical device company committed to maintaining the highest standards of quality and regulatory compliance. They specialize in developing and manufacturing medical devices that meet strict U.S., EU, and international regulatory requirements. With a strong focus on quality assurance and regulatory affairs, they ensure their products meet all necessary safety and compliance standards. Why does this role exist? This position is crucial in maintaining the company's compliance with global regulatory requirements and internal quality standards for medical devices. The specialist will play a vital role in document control, regulatory submissions, and quality system maintenance, ensuring the company's products meet all necessary requirements for market approval and ongoing compliance. The Impact you'll make Quality System Management Maintain and organize quality and regulatory files Oversee calibration and preventive maintenance programs Ensure implementation of corrective actions Monitor compliance with internal procedures Document Control 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) Regulatory Compliance Support international regulatory submissions Prepare Certificates to Foreign Governments Ensure compliance with U.S., EU, and international requirements Monitor regulatory updates and changes Quality Assurance Review product documentation for compliance Support quality system improvements Assist in implementation of corrective actions Maintain quality control processes

Skills, Knowledge and Expertise Required:

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

Your Superpowers:

Documentation management Quality control processes Regulatory compliance understanding Microsoft Office Suite expertise You should apply if… 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 What to expect...

Work Setup:

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

Working Hours:

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

Compensation:

$7 per hour No benefits package included Benefits