About Christie Trilla
Principal Consultant, Wayfinder Advisory
Regulatory Affairs professional with 20+ years in the medical device industry, specializing in building compliance infrastructure from the ground up at Class I/II device startups and emerging growth companies. Deep expertise in FDA submissions (510(k), establishment registration, device listing, UDI/GUDID), QMS development aligned to ISO 13485 and 21 CFR 820, and risk management under ISO 14971.
Proven ability to operate as a first regulatory hire — translating regulatory complexity into sequenced, executable programs that reduce enforcement risk and enable market access. Available for fractional, consulting, and full-time Director-level engagements.
The Path to Wayfinder
Christie has built a career out of walking into companies with no regulatory function and building one from scratch. Most recently, she joined a dental device startup as its very first regulatory hire — with no compliance infrastructure in place, no FDA registration on file, and a product line no one had ever formally reviewed for label compliance. Within months she’d audited seven product lines across 133 SKUs, corrected a mislabeled listing in real time during a live FDA audit, procured the company’s first GS1 prefix, and scoped a 510(k) submission spanning 54 SKUs across four implant systems — the kind of ground-up buildout that has become her signature.
That pattern repeats throughout her work: as an independent consultant, she’s helped early-stage device companies stand up UDI programs and think through predicate strategy before they had a regulatory hire of their own. Earlier, at ZimVie, she took on something similar at a larger scale — developing entirely new regulatory frameworks for tissue-product markets that had no established registration pathway at all, and directing global registrations across Latin America, Asia Pacific, and the Middle East. At DJO, she built the company’s Global Product Registration knowledge base essentially from nothing, turning tribal knowledge into a system the whole organization could use.
Her foundation was built earlier still, in the technical trenches — writing and reviewing 510(k) submissions, managing Design History Files, and providing real-time backroom support during FDA audits at Epimed, Ken Block Consulting, and E4D Technologies, with early roots in product development at Biomet 3i. That hands-on technical grounding is a big part of why she can move as fast as she does when a company brings her in cold: she’s seen what the FDA is actually looking for, from both sides of the table.
Christie holds a Bachelor of Arts in English from Florida Atlantic University — a background that shows up in how she writes regulatory submissions: clearly, precisely, and built to withstand scrutiny.