Compliance Specialist
A top Healthcare product distributor is currently looking to expand by bringing on a Compliance Specialist. This organization is a key leader in the EMS space, delivering high-end healthcare products and services across the nation.
The compliance specialist will be responsible for maintaining regulatory compliance and ensuring the organization is inspection ready. You will monitor ongoing compliance with FDA regulations and ISO standards and be responsible for critical activities that support inspection readiness and continuous development and improvement of the organization.
Essential Duties and Responsibilities:
- Maintain and support organizational compliance with FDA 21 CFR Part 820, ISO 13485, and applicable regulatory frameworks.
- Oversee product identification and labeling controls, including compliance verification and audit support activities.
- Administer complaint handling processes, ensuring timely documentation, tracking, and resolution in accordance with regulatory and quality system requirements.
- Support audit readiness and execution for FDA inspections, ISO certification audits, and internal quality audits.
- Collaborate cross-functionally with Quality, Regulatory, Operations, and other key stakeholders to ensure consistent regulatory alignment.
- Coordinate, administer, and track training initiatives to ensure ongoing compliance with QMS and regulatory obligations.
Skills and Experience:
- Bachelor's degree in a scientific, technical, or related discipline.
- 5+ years of experience in a quality role within the medical device industry.
- Strong working knowledge of FDA 21 CFR 820, ISO 13485, and GUDID requirements.
- Experience in document control and complaint handling process.
- Proficiency with Microsoft Word, Excel, SharePoint, and Docusign.
- Strong Organizational skills.
- Proficiency in Spanish is a plus.
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