We help med tech companies achieve regulatory clearance for novel medical devices, set up the systems they need, and respond to the unexpected.

• Achieved three 510k clearances in under 18 months • Led regulatory market strategies for US, EU, Australia, Canada, and UK.• Responsible for direct negotiation with FDA during in-person (and virtual) meetings• Designed from scratch and implemented 21 CFR 820- and ISO 13485-compliant quality management system in 6 months, to achieve ISO 13485/MDSAP certification• Created regulatory intelligence tracking system to monitor relevant regulations, and standards• Hired and led a team of regulatory and quality staff • Developed forward-looking regulatory submission roadmap to ensure full use of department resources for achieving submission and clearance goals• Served as a member of the Product Strategy Team to advise and review proposed product changes and new product development. • Collaborated with marketing team to design a lightweight but effective advertising and promotional review process• Collaborated with legal counsel to assess and implement requirements for HIPAA and GDPR compliance

• Led preparation of both 510k and de novo device submissions to FDA, and preparation of technical files for EU CE marking• Designed regulatory market strategies for both US and EU• Designed from scratch and implemented 21 CFR 820- and ISO 13485-compliant quality management system in 6 months, to achieve ISO 13485/MDSAP certification• Responsible for direct negotiation with FDA during in-person (and virtual) meetings• Created regulatory intelligence tracking system to monitor relevant regulations and standards• Built and led team of regulatory and quality staff • Served as a member of the Business Authorization Team to review, advise, and approve contracts and vendor agreements • Created cross-functional Clinical Research Group responsible for all product and algorithm validation activities, both internal and external• Served as lead representative in multiple Notified Body audits, all of which were completed with no major findings• Advised on all product development activities in order to ensure desired regulatory classifications were maintained• Collaborated with legal counsel to assess and implement requirements for HIPAA and GDPR compliance

• Regulatory lead on the de novo submission for the first ever direct-to-consumer pharmacogenetics test (authorized October 2018); Achieved FDA authorization of the first ever direct-to-consumer genetic health risk reports for Alzheimer's Disease, Parkinson's Disease, Celiac Disease, and seven other diseases.• Supervision of of Pre-Sub, 510(k), and de novo IVD submission preparation• Regulatory strategy development for new assays and testing methodologies• Review and approval of design, engineering, and labeling changes• Regulatory representation at meetings with FDA• Evaluation of potential new business partners or suppliers• SOP and protocol development and review; Training of staff on new or revised processes• Regulatory intelligence and research to identify new or updated guidances, guidelines, regulations, or standards with the potential to impact company products or processes• Audit and inspection support

• Monitored regulatory information sources daily for potential impact to company products and/or processes on clinical trials, manufacturing, ad/promo, risk management, quality assurance, safety and pharmacovigilance, eCTDs, and pharmacopoeia methods.• Distributed 250-350 new or updated regulations, guidelines, or standards per quarter to appropriate subject matter experts for initial assessment.• Worked with subject matter experts in various functions to assess compliance with new or revised regulations, standards, or guidelines, and to track progress of implementation measures.• Coordinated and managed cross-functional efforts between departments for assessment of regulations with overlapping impact. • Coordinated assessments of international regulations through direct contact with personnel in Japan, China, Portugal, Spain, Germany, and Canada. • Wrote 40-50 executive summaries each quarter for senior management regarding impact, compliance, and implementation of new or updated regulations, standards, and guidelines. • Cultivated new connections with subject matter experts to facilitate distribution and collection of intelligence information.• Managed a database of more than 150 core standards, accessed and utilized by more than 40 global sites.• Maintained and updated department regulatory and compliance assessments database.• Reviewed, updated, and corrected core and regional texts for package labeling and inserts, patient information booklets, and physician guides within Documentum for an OTC product.• Advised RA managers and project leads of relevant laws and standards as necessary to support registrations in key markets.• Served as RA representative on a cross-functional team for comment submission and influencing of ISO and ANSI medical device standards.• Served as RA representative on the cross-functional Safety and Environmental group, monitoring environmental regulations for potential regulatory impact.

• Wrote original chapters for USMLE Step 1 study guide, with comprehensive coverage of numerous subjects, including hematology, immunology, microbiology, gastroenterology, biochemistry, genetics, cardiology, oncology, neurology, embryology, and other topics.• Edited, corrected, and wrote video lecture scripts and study questions for online USMLE Step 1 study course

• Wrote study protocols in compliance with Good Laboratory Practices (GLP) for submission to institutional animal care and use committee.• Researched the role of lymphatic flow in the immune response to both pneumococcal respiratory infection and breast cancer• Designed and implemented protocols for flow cytometric characterization of immune cells from murine tissues, including isolation, surface and intracellular staining, processing, and analysis. • Trained staff and students on proper use of flow cytometers, including protocol setup, compensation, operation, maintenance and calibration, parameter adjustments, and troubleshooting• Collaborated with external clinical organization to perform cytokine and chemokine analyses of human serum as part of multi-site clinical trial• Wrote and revised R01 and R21 grants.• Presented study results directly to physician panel, and collaborated in planning for future studies• Mentored junior lab members on experimental design, analysis and interpretation of data, poster and oral presentation skills, and dissertation/thesis writing

• Researched the role of regulatory T cells in the immune response to Mycoplasma respiratory infections• Developed protocols for flow cytometric analysis of T cell phenotypes for the purpose of identifying new surface markers with high correlation to intracellular factors of interest• Multiplex bead analysis and standard ELISA to measure cytokine levels in serum of mice with experimental respiratory infections, and antigen-specific antibody titers• Extensive experience with both in vitro and in vivo techniques, including cell isolation and adoptive transfer, intranasal infection, serum collection, CFU, real-time PCR, cell culture and stimulation, proliferation assays, immunohistochemistry, and respiratory histology• Performed microbiological studies involving Staphylococcus aureus, using PCR, CFU, bacterial biofilm and cell culture, cloning and transformation, viral transduction, and in vivo biofilm assays

• Co-wrote 510(k) submission for ophthalmological Class II device, cleared by the FDA.• Wrote CSPs, CRFs, IBs, and AE forms for a Phase II clinical trial.• Assisted in the development of product branding and clinical trial branding.• Designed study protocols based directly on physician and investigator recommendations and input.• Product development strategies for increasing patient compliance with usage protocols.

• Wrote ICFs, CSPs, screening questionnaires, and advertising copy in compliance with ICH-GCP guidelines, for IRB approval for both Phase I and Phase II clinical trials.• Wrote CSRs for Phase I clinical trials for client companies and agencies.• Assisted in the development of new recruitment strategies for Phase I patient enrollment.• Led Phase I and Phase II clinical trials.