Tahnee M.
Director, Quality Assurance (Previously Q & R) @Philips Ambulatory Monitoring & Diagnostics
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WORK HISTORY
Director, Quality Assurance (Previously Q & R) @Philips Ambulatory Monitoring & Diagnostics
Malvern, US
Senior Leader responsible for global Quality and Regulatory strategy supporting a $500M ambulatory monitoring and diagnostics business unit within Philips. Lead a 50+ member Quality & Regulatory organization overseeing quality systems, regulatory affairs, compliance, and post-market surveillance activities.Key contributions include:• Front-room lead for multiple FDA inspections with zero Form 483 observations• Direct regulatory engagement with FDA for site inspections, recalls, and compliance activities• Primary liaison with EU Notified Bodies supporting ISO 13485 certification and CE Mark approvals• Led successful ISO 13485 certification and CE Mark approvals through TÜV Rheinland• Directed enterprise Quality Management System aligned with FDA 21 CFR Part 820, ISO 13485, and EU MDR• Led CMS accreditation programs with Healthcare Association on Accreditation (HQAA) and The Joint Commission (TJC)• Directed readiness and response for CMS audits and accreditation surveys / inspections• Oversaw enterprise CAPA, post-market surveillance, vigilance, and corrections & removals programs• Directed regulatory strategy supporting new product introductions and global commercialization
EDUCATION
University of New Orleans
MS Business Administration (Executive MBA), Business Administration
University of Puerto Rico-Mayaguez
BS, Mechanical Engineering
ABOUT TAHNEE M.
Quality and Regulatory Affairs Director / Senior Leader with nearly two decades of experience leading global quality systems and regulatory strategy for medical technology organizations spanning Remote Patient Monitoring, Digital Health, In Vitro Diagnostics, and Hybrid Medtech–Healthcare Service Models.I currently lead enterprise Quality Programs at Philips Ambulatory Monitoring & Diagnostics (AM & D) supporting a $500M ambulatory monitoring and diagnostics business unit, overseeing a 50+ person Quality organization responsible for post market surveillance, corrections & removals, quality & compliance programs, and regulatory readiness. Earlier in my leadership role, I also oversaw both Quality and Regulatory Affairs, guiding regulatory strategy and global compliance initiatives.Throughout my career, I have partnered closely with executive leadership, product teams, and regulators to help ensure innovative medical technologies reach patients safely and efficiently.My experience includes:• Leading FDA inspection readiness programs and serving as front-room lead for multiple FDA inspections with zero Form 483 observations• Direct regulatory engagement with FDA, EU Notified Bodies, CMS, and Accreditation organizations for Pre-Market and Post-Market engagement• Achieving ISO 13485 certification and CE Mark approvals through global regulatory collaboration• Leading CMS Accreditation Programs with Healthcare Quality Association on Accreditation (HQAA) and The Joint Commission (TJC)• Building and leading high-performing Quality organizations of 50+ professionals• Supporting regulatory frameworks for digital health & remote monitoring programsMuch of my work has focused on organizations operating at the intersection of medical devices and healthcare services, where regulatory strategy must address both device compliance and healthcare regulatory frameworks.I am particularly interested in opportunities that enable innovation in remote patient monitoring, digital diagnostics, and emerging healthcare technologies, and I have a personal interest in supporting innovation in women’s health.Regulatory & Quality Expertise:FDA 21 CFR Part 820 | ISO 13485 | EU MDR | IVDR | FDA Inspections | CAPA | Post-Market Surveillance | Medical Device Commercialization | Remote Patient Monitoring | Digital Health | Diagnostics | CMS Accreditation | HQAA | Joint Commission TJC | Quality Management Systems | Regulatory Strategy | Notified Body Engagement
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