FDA Consultant (ISO 13485 & ISO 22716 Experience)

About the role

We are seeking an experienced FDA Consultant to support regulatory compliance, quality system development, and market readiness activities. The ideal candidate will have deep expertise in FDA regulations alongside hands-on experience implementing and auditing quality systems aligned with ISO 13485 (medical devices) and ISO 22716 (cosmetics GMP).

What You Will Do

• 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

What You Will Bring

• 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

About IMSM

IMSM (International Management Systems Marketing) is a global leader in ISO consultancy, offering high-quality ISO standards and services to organisations of all sizes, across all sectors. Whether large or small, we empower businesses worldwide to unlock their potential through tailored, effective ISO certification services. Our mission is to help companies achieve internationally recognised standards, enhancing their operational efficiency and market competitiveness.

In 2024, IMSM was acquired by Inflexion, becoming part of the Axiom GRC division, which expands our capabilities in the areas of Governance, Risk, and Compliance (GRC). With a presence in North America, Canada, APAC, Europe, and Africa, IMSM operates on a global scale, bringing expertise and innovation to businesses everywhere.