Quality Assurance & Regulatory Affairs Specialist

A leading medical device company is hiring a Quality Assurance & Regulatory Affairs Specialist to support compliance with global regulatory standards and maintain robust quality systems. This role is essential for ensuring products meet U.S., EU, and international requirements while supporting documentation and regulatory processes.

Responsibilities:
- Maintain and organize quality and regulatory documentation and files
- Oversee calibration and preventive maintenance programs
- Ensure implementation and tracking of corrective actions
- Manage document control processes for SOPs, forms, IFUs, and ECNs
- Control access to approved documentation and maintain documentation systems
- Review and approve product labeling for compliance
- Process Engineering Change Notices (ECNs)
- Support international regulatory submissions and documentation
- Prepare Certificates to Foreign Governments
- Monitor regulatory updates and ensure compliance with applicable standards
- Review product documentation for quality and regulatory compliance
- Assist in continuous improvement of quality systems and processes

Requirements:
- High School diploma required (Associate degree or higher preferred)
- Proficiency in Microsoft Office Suite
- Strong written and verbal communication skills
- High attention to detail and analytical thinking
- Basic understanding of medical device regulations
- Ability to work in a structured, process-driven environment

Benefits:
- Fully remote work environment
- Opportunity to work in a regulated medical device industry
- Exposure to international regulatory processes
- Hands-on experience in quality systems and compliance management

Join a quality-focused organization where you will play a key role in ensuring product safety, regulatory compliance, and continuous improvement in medical device standards.