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 ...
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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 ...
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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 ...
Remote (USA or India) Engagement: Contract (Part-Time) About the Role We are seeking an experienced Digital Health FDA Consultant with deep expertise in Software as a Medical Device (SaMD) and hands ...
Remote (USA or India) Engagement: Contract (Part-Time) About the Role We are seeking an experienced Digital Health FDA Consultant with deep expertise in Software as a Medical Device (SaMD) and hands ...
Act as the contract liaison for the State agency leadership team . * Ensure ongoing fulfillment of ... Experience in cannabis, marijuana, and/or FDA-regulated industries . * Experience in State ...
Act as the contract liaison for the State agency leadership team . * Ensure ongoing fulfillment of ... Experience in cannabis, marijuana, and/or FDA-regulated industries . * Experience in State ...
Baltimore, MD ยท Remote
$80K - $100K/yr
... contract research organizations (CROs), and regulatory agencies to support the successful execution ... Ensure compliance with FDA regulations, ICH-GCP guidelines, HIPAA requirements, and institutional ...
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Baltimore, MD ยท Remote
$80K - $100K/yr
... contract research organizations (CROs), and regulatory agencies to support the successful execution ... Ensure compliance with FDA regulations, ICH-GCP guidelines, HIPAA requirements, and institutional ...
... ICH-GCP, FDA, and EMA guidelines * Proven ability to negotiate contract terms and manage ... Fully remote working model across Europe with flexibility * Opportunity to contribute to global ...
... ICH-GCP, FDA, and EMA guidelines * Proven ability to negotiate contract terms and manage ... Fully remote working model across Europe with flexibility * Opportunity to contribute to global ...
Raleigh, NC ยท On-site +1
$309K/yr
United States (remote or flexible on-site/hybrid depending on engagement) We are seeking ... Provide practical, business-oriented legal advice on contract terms, risk allocation, and ...
Raleigh, NC ยท On-site +1
$309K/yr
United States (remote or flexible on-site/hybrid depending on engagement) We are seeking ... Provide practical, business-oriented legal advice on contract terms, risk allocation, and ...
OR ยท On-site +1
$309K/yr
United States (remote or flexible on-site/hybrid depending on engagement) We are seeking ... Provide practical, business-oriented legal advice on contract terms, risk allocation, and ...
OR ยท On-site +1
$309K/yr
United States (remote or flexible on-site/hybrid depending on engagement) We are seeking ... Provide practical, business-oriented legal advice on contract terms, risk allocation, and ...
Chicago, IL ยท On-site +1
$309K/yr
United States (remote or flexible on-site/hybrid depending on engagement) We are seeking ... Provide practical, business-oriented legal advice on contract terms, risk allocation, and ...
Chicago, IL ยท On-site +1
$309K/yr
United States (remote or flexible on-site/hybrid depending on engagement) We are seeking ... Provide practical, business-oriented legal advice on contract terms, risk allocation, and ...
OR ยท On-site +1
$309K/yr
United States (remote or flexible on-site/hybrid depending on engagement) We are seeking ... Provide practical, business-oriented legal advice on contract terms, risk allocation, and ...
OR ยท On-site +1
$309K/yr
United States (remote or flexible on-site/hybrid depending on engagement) We are seeking ... Provide practical, business-oriented legal advice on contract terms, risk allocation, and ...
Irvine, CA ยท On-site +1
$160K - $210K/yr
Head of Operations and Manufacturing | California (Hybrid or Remote) | Full-Time POSITION SUMMARY ... selecting contract manufacturers, standing up supply chains compliant with FDA 21 CFR Part 820 ...
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Irvine, CA ยท On-site +1
$160K - $210K/yr
Head of Operations and Manufacturing | California (Hybrid or Remote) | Full-Time POSITION SUMMARY ... selecting contract manufacturers, standing up supply chains compliant with FDA 21 CFR Part 820 ...
Irvine, CA ยท On-site +1
$160K - $210K/yr
Head of Operations and Manufacturing | California (Hybrid or Remote) | Full-Time POSITION SUMMARY ... selecting contract manufacturers, standing up supply chains compliant with FDA 21 CFR Part 820 ...
Irvine, CA ยท On-site +1
$160K - $210K/yr
Head of Operations and Manufacturing | California (Hybrid or Remote) | Full-Time POSITION SUMMARY ... selecting contract manufacturers, standing up supply chains compliant with FDA 21 CFR Part 820 ...
Thousand Oaks, CA ยท Remote
$70 - $80/hr
Contract Duration: 1+ years with likely extensions and/or conversion to permanent Posting Date: 08 ... Experience with auto-injectors, human factors validation, and engagement with the FDA or global ...
Thousand Oaks, CA ยท Remote
$70 - $80/hr
Contract Duration: 1+ years with likely extensions and/or conversion to permanent Posting Date: 08 ... Experience with auto-injectors, human factors validation, and engagement with the FDA or global ...
College Park, MD ยท Remote
... Remote but need to report to the duty station in college park, MD or other FDA facilities within DC metropolitan area as per need) : So, look for local candidates. Duration: Long Term Contract
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College Park, MD ยท Remote
... Remote but need to report to the duty station in college park, MD or other FDA facilities within DC metropolitan area as per need) : So, look for local candidates. Duration: Long Term Contract
New York, NY ยท Remote
$80 - $110/hr
Review audit preparation scenarios involving ISO, FDA, automotive, aerospace, medical device ... Remote structure with competitive hourly compensation Contract Details * Independent contractor ...
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New York, NY ยท Remote
$80 - $110/hr
Review audit preparation scenarios involving ISO, FDA, automotive, aerospace, medical device ... Remote structure with competitive hourly compensation Contract Details * Independent contractor ...
Ensure all contractual activities adhere to relevant regulations, including FDA, NIH, and other ... REMOTE
Ensure all contractual activities adhere to relevant regulations, including FDA, NIH, and other ... REMOTE
... FDA. The Account Executive will lead high-value customer engagement, shape account strategy ... Strong understanding of federal procurement processes, acquisition strategies, contract vehicles ...
... FDA. The Account Executive will lead high-value customer engagement, shape account strategy ... Strong understanding of federal procurement processes, acquisition strategies, contract vehicles ...
... FDA. The Account Executive will lead high-value customer engagement, shape account strategy ... Strong understanding of federal procurement processes, acquisition strategies, contract vehicles ...
... FDA. The Account Executive will lead high-value customer engagement, shape account strategy ... Strong understanding of federal procurement processes, acquisition strategies, contract vehicles ...
... as HHS, NIH, CMS, CDC, and FDA. The candidate must reside within the continental US ... Strong understanding of federal procurement processes, acquisition strategies, contract vehicles ...
... as HHS, NIH, CMS, CDC, and FDA. The candidate must reside within the continental US ... Strong understanding of federal procurement processes, acquisition strategies, contract vehicles ...
... as HHS, NIH, CMS, CDC, and FDA. The candidate must reside within the continental US ... Strong understanding of federal procurement processes, acquisition strategies, contract vehicles ...
... as HHS, NIH, CMS, CDC, and FDA. The candidate must reside within the continental US ... Strong understanding of federal procurement processes, acquisition strategies, contract vehicles ...
San Francisco, CA ยท Remote
$85 - $120/hr
Contract Compensation: $85-$120/hour Location: Remote Commitment: 20-40 hours/week Role ... Familiarity with regulatory portals like FDA , federalregister.gov , NLRB.gov , EEOC . Start Date
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San Francisco, CA ยท Remote
$85 - $120/hr
Contract Compensation: $85-$120/hour Location: Remote Commitment: 20-40 hours/week Role ... Familiarity with regulatory portals like FDA , federalregister.gov , NLRB.gov , EEOC . Start Date
$8.65 - $14.29
1% of jobs
$14.29 - $19.93
5% of jobs
$23.33 is the 25th percentile. Wages below this are outliers.
$19.93 - $25.57
31% of jobs
$25.57 - $31.21
12% of jobs
The median wage is $31.77 / hr.
$31.21 - $36.84
11% of jobs
$36.84 - $42.48
14% of jobs
$43.33 is the 75th percentile. Wages above this are outliers.
$42.48 - $48.12
11% of jobs
$48.12 - $53.76
1% of jobs
$53.76 - $59.40
4% of jobs
$59.40 - $65.03
9% of jobs
$65.03 - $70.67
2% of jobs
$8
$38
$70
| Aspect | Remote Fda Contract | Remote Fda Investigator |
|---|---|---|
| Credentials | Typically requires a background in regulatory affairs, life sciences, or related fields; may need FDA-specific certifications | Requires a background in clinical research, regulatory science, or life sciences; often needs FDA investigator certification or related credentials |
| Work Environment | Contract-based, remote or onsite depending on project; project-specific roles | Primarily remote or onsite inspections, audits, and investigations for FDA compliance |
| Employer & Industry Usage | Used by pharmaceutical, biotech, and medical device companies for regulatory compliance projects | Used by FDA and contract agencies for conducting inspections and investigations |
Remote Fda Contract roles focus on regulatory projects and compliance consulting, often contract-based and project-specific. Remote Fda Investigators conduct inspections and investigations to ensure FDA compliance, often requiring specific certifications. Both roles are vital in the regulatory landscape but differ in responsibilities and work settings.

Full-time
Posted 15 days ago
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.