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FDA Consultant (ISO 13485 & ISO 22716 Experience)

IMSM -
Remote

Apply Now

Job Details

Contract

Qualifications

FDA submissions
Regulatory inspections
Risk management compliance audits
Content creation for technical audiences
Quality records maintenance
Procedural guides
Technical documentation
Gap analysis
GMP
ISO certification audits
Analysis skills
Compliance documentation
Internal compliance assessments
Regulatory/legal compliance standards in production
Quality standards in production
Regulatory submission editing and review
Biomedical regulatory compliance
Technical writing quality assurance
Quality audits
Senior level
Training
Technical writing experience within technology
Risk & issue management
Standard operating procedures (SOPs)
Quality control records management
Communication skills
Audit support

Full Job Description

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.

Department

Operations

Locations

USA Remote

Remote status

Hybrid

Employment type

Contract

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.

Founded in 1994

Co-workers 80+

Turnover 15M

Apply Now

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