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QUALITY ASSURANCE & REGULATORY AFFAIRS SPECIALIST

Advanced Instrumentations, Inc • Miami, FL, US • published 2026-10-28 03:17:06.907505

Description

We are seeking a highly motivated, detail\-oriented Quality Assurance \& Regulatory Affairs Specialist to strengthen our regulatory compliance and quality management operations. The ideal candidate will demonstrate strong technical knowledge, sound judgment, and a commitment to quality excellence, regulatory integrity, and continuous improvement in the medical device industry. Key Responsibilities \- Regulatory Compliance: Ensure adherence to FDA 21 CFR Part 820 (QMSR), ISO 13485, EU MDR, and applicable international medical device regulations. \- Quality Management: Maintain and improve the Quality Management System (QMS), including SOPs, document control, CAPA, nonconformances, complaint handling, and risk management. \- Audits \& Inspections: Coordinate internal and external audits, support regulatory inspections, and ensure timely resolution of findings. \- Regulatory Affairs: Prepare and maintain technical documentation, product labeling, and regulatory submissions for FDA and international markets. \- Continuous Improvement: Promote quality standards, implement corrective actions, and conduct employee training to reinforce regulatory compliance. Qualifications \- Bachelor's d...

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