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Work Background
OPPORTUNEERING NPD, LLCNew Product Development
Mar. 2026Corona del Mar, CAIndependent consulting practice serving medical device, OTC pharmaceutical, cosmeceutical, and consumer health companies on operations, supply chain, product development, quality systems, and NPI commercialization. Engagements span CMO/CDMO management, stage-gate governance, FDA compliance, and operational infrastructure buildout for growth-stage and established regulated CPG businesses.
Patented Dermatologics, LLCFounder — Product Development Venture (In Development)
Mar. 2025Corona del Mar, CAEarly-stage skincare venture leveraging patented transdermal and drug delivery technology. Currently in product development and commercialization planning phase.
Golden Hippo®Director of Product Development
Jan. 2025 - Dec. 2025Los Angeles Metropolitan AreaHigh-growth DTC consumer health and wellness company operating across Amazon, Shopify, and owned direct-to-consumer channels. Portfolio included FDA-regulated OTC Class II dermatological devices, dietary supplement gummies, cosmeceuticals, and personal care.
Led end-to-end product development and supply chain across multiple regulated consumer health categories simultaneously. Key contributions: Sourced and commercialized company's first OTC light therapy dermatological device — managed full supply chain across British and Chinese CMOs, achieving 85% gross margins on low-MOQ programs; generated new revenue in the low millions at annual run rate
Implemented Qualio eQMS from scratch: established DHF/DHR structure, IQC SOPs, CAPA, traceability, and complaint handling infrastructure for FDA-regulated categories
Maintained full regulatory compliance stack: ISO 13485, MDSAP, AER reporting, DRLS, PRRC designation, GUDID registration, and FDA Initial Importer status
Conducted consumer insight generation using Google Trends and primary research reports to identify category opportunities and validate product positioning before development investment
Managed dietary supplement NPI across multi-vitamin superfood gummies, menopause relief capsules, and cosmeceutical exosome formulations
Operated across Deposco WMS, NetSuite ERP, and Salesforce CRM; coordinated cross-functional teams across Quality, IT, Customer Care, Marketing, and Finance
Joylux, IncVP, Operations and Regulatory
Feb. 2024 - Nov. 2024Seattle, WAFemTech medical device company specializing in energy-based personal care devices (Class II) and software as a medical device (SaMD). Recruited to stabilize quality systems, lead regulatory submissions, and rebuild operations infrastructure for a founder-led team.
Owned full VP-level scope across Operations, Supply Chain, Quality, and Regulatory Affairs. Key contributions: Inherited ISO 13485 probation with BSI Notified Body — designed and executed full corrective action plan, rebuilt CAPA, supplier qualification, change control, and deviation management systems end-to-end; restored Notified Body compliance in under 9 months
Oversaw 510(k) clearance process for Class II photo-biomodulation device; managed DHF documentation strategy and leveraged existing biocompatibility and stability data to compress submission timeline
Rebuilt supplier qualification, SCAR, and performance management processes from scratch; restored supply reliability and quality standards across US and Chinese CDMO partners
Drove value engineering of core device platform, identifying design and manufacturing improvements that increased gross margins while maintaining regulatory compliance
Managed multi-modal international fulfillment: B2B, DTC, Shopify, ShipStation, SPS Commerce, Nordstrom RFID compliance, and international freight (air, LCL, LTL, ocean) — optimized logistics saving $20K+ while improving OTIF performance
Maintained full regulatory compliance: ISO 13485, MDSAP, UKAS certification, EU MDR PRRC designation, and Notified Body relationship management with BSI
University Medical PharmaceuticalsVice President Operations
Oct. 2005 - Jun. 2023Irvine, CAFDA-regulated manufacturer of OTC/Rx pharmaceuticals, cosmeceuticals, personal care, and combination medical devices including transdermal delivery systems and iontophoretic wearables. 16-year tenure with progressive VP-level responsibility across Operations, Product Development, Quality, Regulatory Affairs, and Supply Chain.
2014–2023: VP Operations & Combination Product Development Led full commercialization of iontophoretic wearable combination device: IRB-approved clinical study, FDA submission, dual-CM manufacturing scale-up, and multi-channel launch into physician dispensing and specialty retail
Managed dissolvable microneedle array platform with KOL partnerships at Cleveland Clinic, Penn, and UC Irvine; led proof-of-concept studies and patent filings; accepted into UC Irvine University Lab Partners MedTech venture incubator
Drove $35M revenue acceleration in 9 months through OTC category expansion and coordinated commercialization
Managed $25M+ annual CMO/CDMO procurement; built supplier scorecards, SLA enforcement, and QBR cadence 2012–2014: VP Operations & Product Development Co-engineered novel active diffusion dermal delivery system — two granted patents; commercialized WrinkleMD into Bloomingdale's, Harrods, Nordstrom, and Ulta generating $1M+ in new account revenue 2007–2012: VP Operations Built distribution center from scratch generating $1M+ annual freight savings through lane optimization and carrier renegotiation
Delivered $4.3M Year 1 COGS reduction through formulation reverse-engineering and supplier contract restructuring
Established S&OP process, stage-gate NPI governance, and executive KPI reporting infrastructure supporting $200M+ acquisition bids
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