Taylor Gold West

About Taylor Gold West

Accomplished regulatory expert with greater than 13.5 years leading strategy, consulting, compliance, and submissions for innovative medical technologies spanning SaMD, AI/ML, digital health, hardware and implanted products. Proven success at FDA, Medtronic, Philips, consulting firms and startups, including cardiology AI/ML SaMD, with deep expertise in global regulatory pathways, QMS development and implementation, ISO 13485, MDSAP, and cross-functional leadership — consistently enabling business growth and patient access.

Experience

1. Director of Regulatory Affairs

   Anumana

   Oct 2023 — Present · Cambridge, MA, US

   Acted as the primary point of contact for the FDA and international regulatory bodies. Orchestrated all formal communications, including meeting scheduling, briefing document preparation, and direct participation in regulatory hearings- Authored and successfully managed the submission of four 510(k)s, three Q-Submissions, and two IDEs, ensuring high-quality, compliant documentation- Authored Technical Files and General Safety and Performance Requirements (GSPR) to secure CE Marking under EU MDR; led all communications with Notified Bodies and technical review teams- Developed and championed comprehensive regulatory strategies for SaMD, SiMD, MDSS, and CDSS. Partnered with R&D, Clinical, and Marketing to align milestones, budget projections, and corporate objectives- Provided expert regulatory assessments for due diligence activities and advised executive leadership on risk and market pathways- Mentored and managed regulatory staff, fostering professional growth and ensuring team-wide excellence in submission quality and consistency.

Education

• The University of Texas at Dallas

  Master of Business Administration - MBA, Healthcare Admininstration

  2014 — 2016

• The George Washington University

  Bachelor of Science, Biomedical Engineering, Cum Laude

  2008 — 2012