EH

Evelyn Henry

Senior Regulatory Affairs Specialist | IVD & Medical Device Expert

FDA/Global Health Compliance

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Professional Summary

Strategic Regulatory Affairs Leader with 10+ years of expertise ensuring FDA, Health Canada, and ISO 13485/9001 compliance for in-vitro diagnostics (IVD), medical devices, and pharmaceuticals. Proven ability to accelerate approvals, reduce CAPA costs by 79%, and lead 15+ successful FDA 510(k) submissions, consistently cutting time-to-market by 30%.

Specialized in transforming complex regulations into competitive advantages through digital QMS solutions (QT9, Veeva Vault), automated workflows, and North American regulatory strategies. Trusted by global teams for delivering 100% audit readiness, resolving Health Authority queries with 100% on-time responses, and optimizing post-market surveillance to ensure long-term product success.

Regulatory Submissions & Compliance

Expertise in eCTD filings, labeling compliance, and global registrations (U.S./Canada/EU).

Process Optimization

Digitized workflows to eliminate errors, reduce CAPA delays by 40%, and slash documentation review time by 90%.

IVD & Medical Device Leadership

Managed CE Technical Files, clinical performance evaluations, and risk assessments (ISO 14971) for 200+ products.

Cross-Functional Collaboration

Aligned R&D, Marketing, and Legal teams to streamline approvals and drive market-ready innovations.

Adept at training teams, mentoring QA professionals, and leveraging data-driven insights to turn regulatory challenges into scalable business opportunities.

Compliance & Quality Assurance | Digital Transformation | Global Health Compliance

Experienced regulatory leader delivering global submission strategy, QMS transformation, and audit readiness for IVDs and medical devices.

  • Global regulatory experience: FDA, Health Canada, EMA
  • ISO 13485-certified QMS design & audit readiness
  • Digital eQMS & submission automation (Veeva, QT9, Smartsheet)
15+
510(k) & regulatory submissions supported
100%
Audit readiness for core product lines
79%
CAPA cost reduction (digitization)
Keywords
Global Health Compliance Health Canada FDA EMA ISO 13485 QMS CAPA Audit Readiness Risk Management SOPs Digital Transformation Vendor Management

ATS-KEYWORDS: Global Health Compliance; Health Canada; FDA; EMA; ISO 13485; QMS; CAPA; Audit Readiness; Risk Management; SOPs; Digital Transformation; Vendor Management

Performance Metrics

CAPA Resolution Time (Days)

Monthly Compliance Events

Audit Findings Trend

Submission Success Rate

Core Competencies & Technical Skills

Regulatory Compliance & Submissions

  • FDA 21 CFR 210/211/820
  • Health Canada Regulations
  • IVD Compliance (FDA/Health Canada/ISO 13485)
  • eCTD Submissions | Veeva Vault
  • North American Regulatory Strategy
  • Labeling Compliance | Global Registrations (US/Canada/EU)

Quality Assurance & Risk Management

  • Quality Management Systems (QMS)
  • CAPA Management | Root Cause Analysis
  • FDA/ISO Audits | GxP (GMP, GLP, GDP)
  • Post-Market Vigilance (IVD)
  • Deviation Investigations | Risk Management (ISO 14971)

IVD-Specific Expertise

  • In-Vitro Diagnostic (IVD) Submissions
  • Technical Documentation for IVDs
  • CE Technical Files | Product Lifecycle Management (IVD)
  • Clinical Performance Evaluation

Process & Documentation Excellence

  • Technical Writing (SOPs, Protocols, Reports)
  • Regulatory Database Management
  • CMC Documentation | Data Analysis
  • Lean/Six Sigma for Compliance

Leadership & Collaboration

  • Cross-Functional Team Leadership (R&D/Marketing/Legal)
  • Regulatory Training Programs
  • Stakeholder Communication | Health Authority Interactions
  • Project Management for IVD Launches

Technical Tools & Industry Expertise

  • Microsoft Office Suite | SAP | QUMAS | QT9 QMS
  • Smartsheet | IVD Products | Medical Devices | Pharmaceuticals

CERTIFICATIONS & STANDARDS

ISO 13485
ISO 9001
ISO 14001
ISO 19011
ISO 17012
ISO 17021
ISO 11011

Career Highlights

Operational Excellence

  • Achieved ISO 9001:2008 certification through comprehensive quality system implementation.
  • Reduced CAPA-related quality costs by 79% through innovative process redesign and targeted corrective actions.

Digital Transformation

  • Spearheaded paper-to-digital transition of CAPA system, achieving:
    • 100% error reduction (exceeding 80% target)
    • 100% process adherence (surpassing 80% goal)
  • Enabled real-time tracking via Smartsheet implementation for improved transparency and faster decision-making.

Organizational Leadership

  • Developed a standardized departmental procedures manual to ensure consistent, compliant operations across locations.
  • Designed and implemented targeted training programs addressing organizational needs and reducing onboarding time by up to 50%.

DOCUMENTATION & SUBMISSIONS

SOP
NDA
ANDA
510(k)
eCTD
ISO Lead Auditor
MAA
ISO Lead Auditor

Relevant ISO Standards

ISO 19011
ISO 17012
ISO 17021
ISO 11064

Included per client request: ISO standards relevant to audits, conformity assessment, and ergonomic design for regulated environments.

Professional Experience

Senior Regulatory Affairs Associate

Amgen (contractor) | Thousand Oaks

June 2022 - June 2025

Regulatory Strategy & Compliance

  • Orchestrated North American regulatory strategy for 15+ IVD/biopharma products, ensuring compliance with FDA 21 CFR 820 and Health Canada requirements through Veeva Vault RIM, reducing approval timelines by 30% while maintaining 100% submission accuracy for eCTD filings.
  • Led post-market regulatory strategy, maintaining 200+ approved applications through amendments/supplements (CBE-0/30) while leveraging user feedback to drive product enhancements and compliance.

CMC & Process Optimization

  • Served as CMC regulatory SME, providing technical guidance on manufacturing processes and labeling changes to cross-functional teams, reducing review cycles by 40% for US/international markets.
  • Automated regulatory workflows in Veeva (eQMS/CAPA), becoming the "single source of truth" for submissions and cutting deviation resolution time by 50% through real-time tracking.
  • Collaborated with global leads to execute complex CMC projects, assessing reportability of changes and ensuring timely submissions across 5 therapeutic areas.

Senior Complaint Investigator

Meridian Medical Technologies (Pfizer) | St. Louis, MO

June 2020 - March 2021

Complaint & CAPA Management

  • Directed FDA/ISO 13485-compliant investigations for 200+ IVD/medical device complaints, implementing CAPA systems that reduced repeat issues by 40% and achieved 95% on-time closure rate through advanced root cause analysis.
  • Implemented corrective/preventive actions (CAPA) for critical quality issues, reducing repeat complaints by 40% through trend analysis and cross-functional collaboration with QA teams.

Reporting & Process Improvement

  • Automated complaint tracking system, cutting report generation time by 30% while ensuring 100% compliance with FDA 21 CFR Part 820 and Pfizer quality standards.
  • Delivered data-driven insights to senior management through monthly trend reports, influencing product improvements and risk mitigation strategies for 15+ medical devices.
  • Spearheaded expedited complaint resolution process, reducing critical issue escalation time from 72 to 24 hours through Quality Notification Reports and real-time monitoring.

Compliance Investigator

Meridian Medical Technologies (Pfizer) | St. Louis, MO

July 2019 - May 2020

Audit & Query Resolution

  • Championed proactive compliance strategies for FDA/Health Canada audits, reducing findings by 25% across 3 manufacturing sites while streamlining quality processes for IVD products.
  • Led cross-functional responses to 15+ health authority queries and audit observations, ensuring 100% on-time submissions while collaborating with Pfizer Global Supply teams.

Quality Process Streamlining

  • Streamlined quality processes by integrating pest control reports into compliance tracking systems, enhancing documentation accuracy and inspection readiness.

Regulatory Affairs Associate

Titan Spine LLC | Mequon, WI

April 2018 - April 2019

Documentation & Submission Excellence

  • Authored and compiled 510(k) submissions for 5 spinal implant devices, achieving 100% FDA approval rate and reducing review cycles by 25% through meticulous documentation and cross-functional collaboration with R&D.
  • Developed and maintained technical files for EU MDR compliance, ensuring seamless market access for 10+ medical devices across global markets.

Change Control & Process Improvement

  • Managed change control processes for product modifications, ensuring 100% regulatory compliance and minimizing market disruption through proactive risk assessments.
  • Reduced documentation review time by 30% by implementing standardized templates and approval workflows, enhancing efficiency across regulatory operations.

Quality Assurance Specialist

Sigma Aldrich | St. Louis, MO

April 2015 - April 2018

QMS Implementation & Optimization

  • Spearheaded IVD compliance initiatives using QUMAS, reducing document review time from 2 weeks to 2 days and ensuring 100% audit readiness for FDA/ISO 13485 inspections across 3 manufacturing sites.
  • Managed CAPA/deviations in the eQMS, achieving 95% on-time closure rate and reducing repeat issues by 30% through robust root cause analysis and preventive action plans.

Data Analysis & Reporting

  • Generated monthly quality metrics reports for senior management, driving data-informed decisions that improved product quality and reduced compliance risks by 25%.
  • Conducted internal audits and supplier evaluations, enhancing supply chain quality and ensuring adherence to cGMP and ISO standards for 50+ critical materials.

Education & Certifications

Education

Bachelor of Arts in Management, Emphasis in Health Relations
Webster University — 2014
St. Louis
Associate of Applied Science in Clinical Laboratory Technology
Forest Park Community College — 1984
St. Louis

Certifications

  • ISO 13485 – BSI Management System (Certificate #4421555-20)
  • ISO 9001 – BSI Management System