FDA Consultant, ISO 13485, ISO 22716 Experience

IMSM

FDA Consultant supporting regulatory compliance efforts and quality system development at IMSM. Involves guiding FDA submissions, maintaining QMS aligned with ISO standards, and ensuring product compliance.

Posted 5/1/2026contract🇺🇸 United StatesMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Flexible work arrangements
Support regulatory compliance
Market readiness activities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

FDA regulatory requirements510(k) submissionsQuality Management Systems (QMS)ISO 13485ISO 22716gap analysesinternal auditsSOPstechnical documentationrisk management

Soft Skills

communicationanalytical skillstrainingstrategic guidance

Certifications

Regulatory Affairs Certification (RAC)