FDA Consultant (ISO 13485 & ISO 22716 Experience)

Freelance FDA Consultant (ISO 13485 & ISO 22716 Experience)

USA Remote (with occasional on-site client visits)

Contract / Self-Employed Basis

About IMSM

IMSM (International Management Systems Marketing) is a global force in ISO consultancy - helping organisations not just achieve certification, but transform the way they operate. We partner with businesses across every sector, elevating performance, boosting compliance and unlocking measurable competitive advantage.

Now part of the Axiom GRC division within the WorkNest group and backed by Inflexion, we bring the reach and resources of a worldwide organisation. With teams spanning the UK, Europe, North America, APAC, Africa and Canada - and a growing network of 85 employees and more than 350 expert contractors enables us to deliver high-quality, results-driven ISO consultancy to clients worldwide.

The Opportunity

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 and have expertise in management systems and relevant standards

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

Join Our Global Contractor Community

As part of the WorkNest group and the wider Axiom GRC division, you will contribute to a powerful network of more than 800 experts shaping the future of Governance, Risk and Compliance services.

If you are a dedicated ISO professional looking for flexible, rewarding work with a market leading consultancy, we would love to hear from you.