What are the responsibilities and job description for the Quality & Regulatory Compliance Manager position at Audrey Morris Cosmetics Internation?
Quality & Regulatory Compliance Manager
Location: Boca Raton, FL
Hairmax is seeking a skilled professional to lead and manage our Quality Management System and Regulatory Compliance efforts for medical devices, dietary supplements, and cosmetics. This role ensures compliance with ISO 13485, FDA regulations, and EU MDR requirements while driving quality improvements and overseeing risk management across the product lifecycle.
Key Responsibilities:
• Oversee the Quality Management System and ensure regulatory compliance.
• Manage audits, risk management, supplier quality, and employee compliance training.
• Lead pre-market approvals (e.g., 510K) and maintain global regulatory intelligence.
• Collaborate cross-functionally to ensure claims, product development, and compliance.
Qualifications:
• 5-7 years of experience in quality systems (ISO 13485, FDA regulations, EU MDR).
• Preferred: Experience with Class II medical devices, GMP, and cosmetics.
• Certified ISO 13485 internal auditor is a plus.
Join Hairmax and contribute to groundbreaking solutions in hair health.
Apply today to be part of our innovative team!
Salary : $50,000 - $120,000