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 youll 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

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