FDA Consultant, ISO 13485, ISO 22716 Experience

Role Overview

• Provide strategic guidance on FDA regulatory requirements, including submissions, compliance, and inspections
• Lead or support FDA submissions (e.g., 510(k), cosmetic product compliance, facility registrations)
• Develop, implement, and maintain Quality Management Systems (QMS) compliant with ISO 13485 and ISO 22716
• Conduct gap analyses and internal audits to assess compliance readiness
• Support preparation for FDA inspections and notified body audits
• Review and author SOPs, technical documentation, and quality records
• Advise on risk management processes and product lifecycle compliance
• Ensure alignment between US FDA regulations and international standards
• Train internal teams on regulatory requirements and quality standards
• Liaise with regulatory authorities and external stakeholders as needed

Requirements

• Proven experience as an FDA consultant or regulatory affairs specialist
• Strong knowledge of FDA regulations (e.g., 21 CFR Parts 210, 211, 820, and cosmetics regulations)
• RAC (Regulatory Affairs Certification) or equivalent
• Demonstrated experience with: ISO 13485 (Medical Devices Quality Management Systems)
• ISO 22716 (Cosmetic Good Manufacturing Practices)
• Experience supporting FDA inspections and/or notified body audits
• Excellent documentation, communication, and analytical skills

Benefits

• Flexible work arrangements
• Support regulatory compliance
• Market readiness activities