Key Responsibilities

• Serve as the designated Management Representative for quality and regulatory compliance matters.
• Lead preparation for, host, and directly interface with FDA, ISO, and Notified Body audits; manage corrective actions and close-outs.
• Assess, streamline, and optimize the company’s Quality Management System (QMS) for efficiency, compliance, and scalability.
• Provide expert guidance on FDA regulations (21 CFR Part 820, 803, 11, 4, etc.), ISO 13485, MDSAP, and applicable international standards.
• Develop and oversee compliance strategies to support product development, manufacturing, and postmarket activities.
• Collaborate cross-functionally with R&D, Operations, Clinical, and Regulatory teams to ensure alignment with QMS requirements.
• Lead internal audit programs, CAPA management, and risk management processes.
• Train and mentor internal teams on quality and compliance best practices.
• Support regulatory submissions and technical documentation as needed.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field (advanced degree preferred).
• 10+ years of progressive experience in Quality Assurance, Regulatory Compliance, or related functions within the medical device industry.
• Strong track record serving as a Management Representative and leading FDA/ISO audits with successful outcomes.
• In-depth knowledge of QMS implementation and optimization, including document control, CAPA, complaint handling, supplier quality, and risk management.
• Hands-on experience with orthopedic and/or spinal medical devices highly preferred.
• Expertise in FDA regulations, ISO 13485, MDSAP, EU MDR and other global regulatory frameworks.
• Exceptional communication, leadership, and problem-solving skills with the ability to work independently and instill confidence as a trusted advisor.