What are the responsibilities and job description for the Regulatory Compliance Specialist position at GL Staffing?
Job Title: Quality Specialist - Change Control System
We are seeking a highly organized and detail-oriented individual to manage the Change Control System. This role involves overseeing the documentation, review, and approval of change requests, analyzing risk assessments, and ensuring compliance with regulatory standards.
This is an exciting opportunity for a professional who thrives in a fast-paced environment and is passionate about maintaining quality standards.
Key Responsibilities:
- Manage the change control process, ensuring all change requests are documented, reviewed, and approved.
- Analyze risk assessments for proposed changes and identify potential impacts.
- Coordinate updates to documents and training as needed.
- Maintain accurate records throughout the change control process.
- Collaborate with teams across the organization to ensure smooth change implementation.
- Support FDA inspections and external audits by providing required documentation.
- Continuously review and improve the change control process to maintain quality standards.
- Evaluate and implement new processes to ensure compliance with regulatory standards and internal policies.
Requirements:
- Bachelor's degree in a relevant field or equivalent work experience.
- Minimum of 3 years of experience in change control, document management, or training program management in a regulated environment, preferably within the medical device industry.
- Strong organizational skills, attention to detail, and the ability to multitask.
- Proficient in Microsoft Word, Excel, and Outlook.
- Experience in analyzing risk assessments and ensuring regulatory compliance.
