Six engagements that show what embedded regulatory leadership looks like when it lands — inside the world’s largest device companies, ambitious diagnostics innovators, and the agency itself.
No composite case studies. No borrowed war stories. Every engagement on this page was led in person by the leadership behind this firm — told the way we’d tell it across the table: what we walked into, what we owned, and how it ended.
The mandate: J&J MedTech’s orthopaedics business runs supply-chain change at a scale most companies never see — and every supplier transfer touches regulatory ground in dozens of markets. Reporting to the Director of RA Program Management for Special Projects, our consultant owned the regulatory line on cost-improvement transfer projects across the portfolio.
The work: regulatory impact assessments to decide what each change truly triggered, regulatory strategy for the markets it touched, and execution of the actions that followed — Technical File updates and 510(k) notes-to-file — while keeping cross-functional teams moving.
How it ended: three years, thirty-plus supplier-transfer projects, and collective cost savings measured in the millions — delivered without regulatory surprises.
The mandate: a diagnostics innovator with groundbreaking products moving fast toward market — and regulatory and quality workstreams that had to keep pace across every one of them at once.
The work: owning regulatory affairs and quality deliverables across six product launches, building the Risk Management File for each, driving the organization’s ISO 13485:2016 implementation, and leading the integration of SAP Business One quality system software so compliance tracking kept up with the engineering.
How it ended: six products launched on a quality system that was certified, digitized, and built to outlast the engagement.
ProPlate’s Quality Manager left with the ISO 13485 notified body audit already on the calendar. This is the call most firms answer with a proposal. We answered it with a person — on site, accountable, and ready to stand in the audit room.
Quality Manager gone, audit weeks out, open CAPAs and unresolved ISO 14971 gaps waiting.
Open CAPAs driven to closure; risk-management gaps against ISO 14971 remediated file by file.
A full internal audit executed before the notified body’s — so nothing in the room was a surprise.
The organization supported through the audit itself — questions answered, evidence produced, certification defended.
Unique Device Identification only works if every record is right. At Boston Scientific, our consultant led implementation of the Global UDI Database (GUDID) and managed regulatory document preparation and submission across multiple regions — keeping device data airtight while supporting the post-market activities that carried products to approval and market readiness.
For Smiths Medical’s US Class II and III devices, our consultant owned regulatory documentation and post-market compliance — converting legacy technical files to the Summary Technical Documentation (STED) format, streamlining the documentation system, and keeping it inspection-ready through disciplined CAPA responses.
Before advising sponsors, our consultant sat on the other side — at FDA, shadowing agency reviewers and supporting the technical review of live 510(k) and PMA submissions, researching and evaluating sponsor dossiers alongside the people who decide them.
Why it matters to you: that reviewer’s-eye view — what earns questions, and what earns clearance — now shapes every submission we build.
FDA White Oak Campus · Silver Spring, MD
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