FDA Consultant (ISO 13485 & ISO 22716 Experience)

IMSM•New York, NY

11h•Remote

About The Position

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).

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)
Demonstrated experience with: ISO 22716 (Cosmetic Good Manufacturing Practices)
Experience supporting FDA inspections and/or notified body audits
Excellent documentation, communication, and analytical skills

Responsibilities

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 and have expertise in management systems and relevant standards