Track record
Built and run — not advised on.
Nearly two decades in senior industry roles, plus consulting and coaching mandates — every entry below was mine to deliver, with the accountability that came with it. Each is tagged with the milestone it belongs to.
Strategize
Regulatory pathway for new products
Set product classification and regulatory pathway at the front of new product development — for portfolio additions at mid-size manufacturers and for first products at start-ups — with the business case that had to hold up alongside it.
ClassificationPathwayBusiness case
Implement
Class III implant — ideation to launch
Led the interdisciplinary NPD team through development of a Class III medical device: design control and risk management file, pre-clinical and clinical program, process validation, scale-up and supplier build-up — through to market.
Class IIIDesign controlISO 14971Scale-up
Assure
QMS certification readiness
Set the quality plan, ran the gap analysis against the applicable laws and standards — ISO 13485, EU MDR, 21 CFR 820 — then implemented the system in the company: SOP landscape and templates restructured to the eQMS data model (Matrix Requirements / MatrixALM), design control and technical documentation built inside it. Brought to certification readiness, holding the management representative role with personal accountability.
ISO 13485EU MDR21 CFR 820Gap analysisMatrixALM
Strategize
Feasibility and NPV ahead of the go decision
Assessed product and project feasibility at the front of the stage-gate — technical route, regulatory exposure and NPV — for portfolio additions at mid-size manufacturers and first products at start-ups, so the go decision rested on numbers rather than conviction.
FeasibilityNPVStage-gatePortfolio
Implement
Multi-center clinical investigations, Europe & Asia
Designed and ran multi-center clinical investigations to ISO 14155 and GCP, managing CROs and monitoring — and produced the clinical evaluations and post-market follow-up that keep a device certified.
ISO 14155GCPCRO managementCER
Assure
Due diligence before capital was committed
Assessed innovations and acquisition targets for technical feasibility, IP position and regulatory exposure — for management teams and boards deciding where to invest, with a clear remediation roadmap attached.
Technical DDIPRegulatory risk
Assure
Supplier qualification, audits and monitoring
Selected and qualified critical suppliers, negotiated the quality and supply agreements behind them, then kept them under a planned audit cycle alongside internal audits — findings tracked to closure. Certified Lead Auditor for ISO 13485 and ISO 9001, external auditor to ISO 19011.
Certified Lead AuditorSupplier qualificationQAAISO 19011
Assure
Independent reviewer on development projects
I have sat on both sides of the design review: leading the project team whose work was being judged, and later, as R&D head, monitoring progress across a portfolio and deciding what was ready to pass its stage gate. That is the qualification an independent reviewer needs — knowing what the evidence should look like, and what it costs the team to produce it.
Independent reviewDesign reviewsStage gatesDesign control
All three
The clinical story, from evidence to audience
Defined what the evidence actually supports and shaped it into a clinical story — then built the plan to carry it: webinars, white papers and consensus work with opinion leaders, dissemination through web and social channels, and review of marketing collateral and website content against the data.
Clinical storytellingMedical communicationClaim substantiationKOL
Delivered in senior line roles and coaching engagements — details and references on request.
