FDA Consultant (ISO 13485 amp; ISO 22716 Experience)

divh2Freelance FDA Consultant (ISO 13485 ISO 22716 Experience)/h2pUSA Remote (with occasional on-site client visits)/ppContract / Self-Employed Basis/ppAbout IMSM/ppIMSM (International Management Systems Marketing) is a global force in ISO consultancy - helping organizations 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./ppNow part of the Axiom GRC division within the WorkNest group and backed by Inflexion, we bring the reach and resources of a worldwide organization. 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./ppThe Opportunity/ppWe 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)./ppWhat You Will Do/pulliProvide strategic guidance on FDA regulatory requirements, including submissions, compliance, and inspections/liliLead or support FDA submissions (e.g., 510(k), cosmetic product compliance, facility registrations)/liliDevelop, implement, and maintain Quality Management Systems (QMS) compliant with ISO 13485 and ISO 22716/liliConduct gap analyses and internal audits to assess compliance readiness/liliSupport preparation for FDA inspections and notified body audits/liliReview and author SOPs, technical documentation, and quality records/liliAdvise on risk management processes and product lifecycle compliance/liliEnsure alignment between US FDA regulations and international standards/liliTrain internal teams on regulatory requirements and quality standards/liliLiaise with regulatory authorities and external stakeholders as needed and have expertise in management systems and relevant standards/li/ulpWhat You Will Bring/pulliProven experience as an FDA consultant or regulatory affairs specialist/liliStrong knowledge of FDA regulations (e.g., 21 CFR Parts 210, 211, 820, and cosmetics regulations)/liliRAC (Regulatory Affairs Certification) or equivalent/liliDemonstrated experience with:/liulliISO 13485 (Medical Devices Quality Management Systems)/liliISO 22716 (Cosmetic Good Manufacturing Practices)/li/ulliExperience supporting FDA inspections and/or notified body audits/liliExcellent documentation, communication, and analytical skills/li/ulpJoin Our Global Contractor Community/ppAs 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./ppIf you are a dedicated ISO professional looking for flexible, rewarding work with a market leading consultancy, we would love to hear from you./p/div