About the ClientOur 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.
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
United States
Philippines only
AU, CA + 3 more
CA and US only