EH

Evelyn Henry

Senior Regulatory Affairs Specialist | IVD & Medical Device Expert

FDA/Health Canada Compliance

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Professional Summary

Strategic Regulatory Affairs Leader with 20+ 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

COMPLIANCE
QUALITY ASSURANCE
TRANSFORMATION
DIGITAL
101 10110 0100 1100

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

NDA
FMA
ISO 9001
ISO 13485
510(k)
ISO 14001

Career Highlights

Regulatory Excellence

  • Achieved ISO 13485 certification for IVD products.
  • Reduced CAPA-related costs by 79% while maintaining 100% FDA/Health Canada compliance.
  • Spearheaded 5+ successful FDA 510(k) submissions, accelerating time-to-market.

Digital Transformation

  • Led paper-to-digital transition (QT9 QMS, Veeva Vault) achieving 100% error reduction.
  • Real-time tracking of FDA/Health Canada submissions via Smartsheet.
  • 40% faster audit readiness through automated workflows.

North American Leadership

  • Developed standardized regulatory procedures for US/Canada IVD submissions.
  • Designed and delivered compliance training for 50+ QA/RA professionals (50% onboarding time reduction).
  • Resolved 15+ health authority queries with 100% on-time response rate as FDA/Health Canada liaison.

Process Optimization

  • Spearheaded IVD compliance at Sigma Aldrich with QUMAS, reducing document review time from 2 weeks to 2 days.
  • Cut CAPA costs by 79% by digitizing workflows with QT9 QMS, eliminating paper-based errors.
  • Developed Smartsheet-powered eQMS that boosted CAPA adherence to 100% and reduced corrective action delays by 40%.

PROCESS OPTIMIZATION

Professional Experience

Senior Regulatory Affairs Associate

Amgen (contractor for Ampcus) | 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 Associate

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.

DOCUMENTATION & SUBMISSIONS

SOP
NDA
ANDA
510(K)
eCTD
MAA

Education & Certifications

Education

  • Master of Science (M.S.), Regulatory Affairs - St. Cloud State University, MN
  • Bachelor of Science (B.S.), Biology - University of Missouri, St. Louis

Certifications

  • Regulatory Affairs Certification (RAC) - Regulatory Affairs Professionals Society (RAPS)
  • ISO 13485:2016 Lead Auditor - Exemplar Global
  • Certified Quality Auditor (CQA) - American Society for Quality (ASQ)
  • Lean Six Sigma Green Belt - ASQ