Summary
Overview
Work History
Education
Skills
Training
Timeline
Generic

Martha E. Conroy

Howell

Summary

A committed and forward-thinking Regulatory Affairs and Quality Assurance Leader with 10+ years of experience in ISO environments, specializing in Class II & IVD medical devices. Proven track record of efficiency, detail orientated, and achieving goals. Skilled in team management, problem-solving, and high-risk medical product development. Bilingual in English and Spanish with multicultural experience. Strong ability to manage complex matrix environments and prioritize workload while focusing on patient and client needs.

Strong focus on team collaboration and delivering results. Adaptable and reliable, skilled in risk management, regulatory strategy, and stakeholder communication.

Overview

13
13
years of professional experience

Work History

Senior Regulatory Affairs Specialist

Meridian Bioscience, Inc.
10.2024 - Current
  • Led the preparation and submission of Class C and Class B IVDR Technical Documentation (TD) updates in accordance with EU 2017/746.
  • Conducted gap assessments and remediation plans for legacy CE-marked products transitioning from IVDD to IVDR classification.
  • Mentored junior regulatory staff, fostering professional growth and sharing industry knowledge to enhance overall team performance.
  • Maintained up-to-date knowledge on evolving regulations, participating in industry conferences and educational events to ensure continued expertise in the field.
  • Streamlined regulatory submissions by supporting the development of efficient processes and documentation templates and checklists.
  • Acted as primary liaison with Notified Bodies, Competent Authorities, and Authorized Representatives for post-market technical file updates, change notifications, and regulatory correspondence.
  • Collaborated cross-functionally with QA, R&D, and Clinical Affairs to assess the regulatory impact of design and manufacturing changes on registered products
  • Supported global expansion efforts by researching international regulatory requirements.
  • Supported external audits and inspections by preparing and presenting post-market regulatory evidence, corrective actions, and historical submission data.
  • Implemented regulatory guidance procedures for regulatory change evaluations in an effort to promote efficiency.
  • Acted as Regulatory Affairs lead for veterinary biologics, supporting USDA CVB establishment licensing, product licensing, and facility registration in compliance with 9 CFR requirements.

Manager, Design QA

QIAGEN
06.2022 - Current
  • Responsible for oversight, maintenance, monitoring and improvement of Quality Management System processes in the area of Design Controls, Change Management, and the development, implementation and management of Labeling Design Control processes for IVD NeuMoDx Molecular System Platform in compliance with FDA Medical Device Quality System Regulations (QSR), ISO 13485 and MDSAP for Global NeuMoDx IVD division.
  • Instituted and monitored Bi-Monthly Change Review Board Meetings to ensure appropriate reporting and review is maintained and actions are appropriately completed according to established timelines.
  • Prepared reports on quality system activities, including Bi-annual Management Review, Monthly Global QA Meetings, and Monthly Global Operations meetings.
  • Oversaw and provided counsel on the compliance of New Product Development (NPD) and Lifecycle Management (LCM) of DHF and DMR documentation to assure compliance with ISO, FDA regulations and cGMP.
  • DQA Core Team member in the Design and Development Transition Projects from IVDD to IVDR of Class C and Class D product Assays achieving IVDR certification as well as 510k clearance.
  • Participated in the development and approval of Standard Operating Procedures (SOP) across diverse functional areas of the division including but not limited to: SOPs, work instructions, forms, templates, employee training, record retention, change control, customer communications.
  • Drove site-wide compliance by successfully leading the integration of Global Design, Development and Product and Document Change Control QMS Processes by bringing them into compliance under QIAGEN Global QMS umbrella through strategic planning and close collaboration with global teams.
  • Achieved over 55% year-over-year reduction across all key process indicators (KPI’s) through targeted review and process improvement.
  • Implemented 5 PDCA initiatives for continuous improvements across the established processes.
  • QA Core Lead in the outsourcing of production manufacturing for the NeuMoDx System to contract manufacturers, including maintaining proper lines of communication with contract manufacturer, supporting the establishment of processes related to product reworks, inspection and release in accordance with all applicable regulations, drafting and collaborated cross functionally on Supplier Quality Agreement.
  • Audit Lead in managing ISO 13485 and MDSAP surveillance and re-certification audits, including audit schedule and audit agenda with notified bodies.
  • Significantly reduced ISO 13485 and MDSAP findings from eleven nonconformances to zero nonconformances through the execution of 2 surveillance and 1 recertification audit.
  • CAPA Team Lead- focused on issue identification, risk assessments, root cause analysis, investigations and data analyze in support of corrective and preventative actions.
  • Approver of OOS and Deviations that require DQA approval and assessment.
  • Maintaining communication with Regulatory Bodies (FDA), Notified Bodies (BSI) and Authorized Representative (Emergo) on QMS and Design Changes following Change Notification processes.
  • Member of Site Leadership Panel driving strategic planning for NeuMoDx Platform Franchise improvement projects, serving as QA representative and chaired the Diversity, Equity, and Inclusion Committee, overseeing DEI initiatives site wide.
  • Managed and developed personnel within Design Quality Assurance, Change Control, and Labeling departments, including department budget oversight.

Design Quality Assurance, Engineer II

Terumo Cardiovascular, LLC
06.2021 - 05.2022
  • Supported Design and Development Changes for the Class II Heart and Lung device CCMD Module.
  • Ensured accuracy and compliance of all supporting documentation with Terumo QMS and regulatory requirements for domestic and international regulations.
  • Internal company certified trainer as Design Controls Subject Matter Expert (SME).
  • Facilitated and supported the risk management process for assigned projects.
  • Project lead in transferring risk management documentation to comply with updated ISO 14971 regulation.

Senior Regulatory Affairs and Quality Assurance Specialist Lead

HoMedics, LLC
07.2018 - 05.2021
  • Led the planning and implementation of a comprehensive quality system achieving ISO 13485 and MDSAP certification. Developed processes for product development, manufacturing, and operations.
  • Provided QARA input and oversight of Life Cycle Management planning with regards to product risk management and monitoring of data associated with product lifecycle.
  • Ensured accuracy and compliance of all supporting documentation with regulatory requirements for domestic and international markets.
  • Reviewed and reduced product design changes for regulatory impact.
  • Reviewed and recommended changes for labeling, advertising, and promotional marketing literature to ensure regulatory compliance.
  • Compiled and maintained product technical information including change information in support of market expansion.
  • Communicated with authorized representatives and regulatory agencies for market release approval, compliance issues, and external audits. Maintained strong relationships with notified body agencies.
  • Coordinated, monitored, and addressed notified body audit findings.
  • Supported the design, implementation, and management of post-market surveillance, customer feedback, complaint handling, and medical device/vigilance reporting. Served as an internal consultant on regulatory issues such as recalls or field actions.
  • Implemented and managed Quality System processes including Supplier Corrective Action Requests (SCAR), Non-conformance Reports (NCR), Corrective and Preventive Actions (CAPA).
  • Conducted training sessions for new hires, quality assurance, regulatory compliance, and team building. Designed and configured SharePoint for managing document control, CAPA, NCR, customer feedback, complaint handling, calibration, approved supplier list, deviations, Design History Files (DHF), and product development projects.

Regulatory Affairs and Quality Assurance Specialist

HoMedics, LLC
10.2016 - 07.2018
  • Led process improvement efforts in my assigned categories utilizing tools such as Pareto charts, process flow charts, basic statistics, and control charts.
  • Member of product development team that help support drafting, evaluation and review of protocols and data in support of Design Controls and Clinical V&V activities.
  • Planned suitable verification, validation, qualification, and testing plan methods that were consistent with Homedics Quality System and compliant with both ISO 9001 and ISO 13485 standards.
  • Investigated customer complaints, analyzed the data using statistical analysis and communicated findings to our China based supplier quality team leads for improvements.
  • Performed detailed analysis of returned customer products and used findings to drive Corrective and Preventative Action (CAPA) improvements of current and future product designs.
  • Member of cross-functional team that reviewed, analyzed, tested, and approved all engineering product changes.
  • Supported numerous medical device product launches to comply with all FDA standards.
  • Lead cross-functional teams through the 8D process to identify the root cause of failures.
  • Participated in internal audits and responded to findings.
  • Lead critical Supplier quality issues for timely resolution and monitored the effectiveness of product improvement.
  • Built working partnership with China based suppliers to ensure product quality and improve score card performance.

Industrial Process Engineer

Protech Global Solutions, LLC
06.2012 - 10.2015
  • Supported the development of a new manufacturing area, overseeing design through to mass production operations.
  • Updated and maintained facilities layout for Surface Mount Technology (SMT) and hand assembly processes for PCBs.
  • Developed working instructions, time standards, and quality specifications for all SMT processes.
  • Member of the Design for Manufacturing (DFM) team, ensuring timely product launches and quality goals achievement.
  • Participated as a New Product Introduction (NPI) pilot run member, collaborating with design engineering to optimize manufacturing approaches.
  • Developed and managed assembly line processes using PFMEA, Document Control, Deviations, and Engineering Changes.
  • Collaborated with suppliers to resolve quality issues related to production materials.
  • Led NPI line design, balancing, installation oversight, and acceptance.
  • Trained Technicians and Operators on new equipment, devices, processes, lean manufacturing, and Six Sigma tools.
  • Communicated with suppliers to clarify specifications, drawings, and overall performance aligned with ISO-9001 quality system requirements.

Education

Bachelor of Science - Industrial Engineering

University of Texas at El Paso
El Paso, Texas
05.2015

Skills

  • FDA regulatory experience
  • ISO certification experience
  • Comprehensive auditing skills
  • Product lifecycle management
  • Quality Management System
  • Continuous Improvement
  • Management
  • Mentoring
  • Regulatory strategy
  • Labeling compliance
  • Global regulatory compliance
  • Risk management
  • Audits
  • Teamwork and collaboration
  • Problem-solving
  • Leadership skills
  • Effective communication
  • Adaptability and flexibility
  • Decision-making
  • Goal setting
  • Strategic planning

Training

  • Six Sigma Green Belt: Independent Institute of Education (IIE), El Paso, Texas April 2012-Learned how to define problems, identify performance measures and implement effective solutions all through lean six sigma methodology.
  • Project Management Fundamentals I: QIAGEN, Ann Arbor MI January 2024- Identify the key processes and requirements of project management by the hands on execution of project initiation, assessment of time and cost, planning for project risks, communication and change control. Execution, management and control of the project as well as final closure of project.
  • Design Control Requirements - Integrating the Quality System Regulation: AAMI, Washington, DC October 2018
  • Design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP)
  • Cultivate- First Line manager Training: KOAP, Germantown, MD June 2023- Growth Mindset, Pressure/Performance & brand, Leadership pipeline, SCARF.
  • 2025 Veterinary Biologics Training Program: IICAB, Ames, IA, May 2025- Overview of the USDA regulatory process for assuring the purity, safety, potency, and efficacy of veterinary biologics (vaccines, bacterin, antisera, diagnostic kits, and other products of biological origin)

Timeline

Senior Regulatory Affairs Specialist

Meridian Bioscience, Inc.
10.2024 - Current

Manager, Design QA

QIAGEN
06.2022 - Current

Design Quality Assurance, Engineer II

Terumo Cardiovascular, LLC
06.2021 - 05.2022

Senior Regulatory Affairs and Quality Assurance Specialist Lead

HoMedics, LLC
07.2018 - 05.2021

Regulatory Affairs and Quality Assurance Specialist

HoMedics, LLC
10.2016 - 07.2018

Industrial Process Engineer

Protech Global Solutions, LLC
06.2012 - 10.2015

Bachelor of Science - Industrial Engineering

University of Texas at El Paso

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