Devin Fierro

Work History

HEAD OF REGULATORY

TITIN KM BIOMEDICAL

Bozeman

03.2024 - 06.2025

Accomplished Regulatory Manager with extensive experience leading regulatory affairs in the medical device industry, ensuring compliance with international regulations, and supporting successful product development and commercialization.
Demonstrates a comprehensive understanding of the FDA, EU MDR, ISO 13485, and other global regulatory frameworks. Adept at developing regulatory strategies that align with business goals, preparing and submitting high-quality regulatory submissions (510(k), PMA, CE marking), and managing interactions with regulatory authorities.
Effectively leads cross-functional teams in the creation and maintenance of technical documentation, risk assessments, and labeling to support global market access.
Proven track record in facilitating regulatory approvals and product registrations in diverse markets, including North America, Europe, Asia-Pacific, and Latin America.
Skilled in monitoring regulatory changes and proactively advising internal stakeholders to mitigate compliance risks.
Recognized for strong leadership in audits and inspections, regulatory due diligence during mergers and acquisitions, and post-market surveillance activities.
Passionate about driving quality and patient safety while enabling innovation through clear, compliant, and strategic regulatory oversight.
Managed ISO 13485/9001 certification efforts. Ensured the Quality Management System was suitable, effective, and compliant.

QUALITY ASSURANCE MANAGER

ONDINE BIOMEDICAL

Bothell

11.2022 - 08.2023

Managed CAPA program, including root cause analysis, plans, verification, and closure.
Conducted internal audits of processes, products, and systems to ensure compliance with quality standards.
Oversaw complaint program, conducting thorough investigations on reported issues.
Investigated customer feedback and developed strategies for addressing complaints quickly and efficiently.
Developed personnel within QA department to enhance team capabilities.
Conducted data analysis to prepare metrics aligned with quality objectives.
Supported internal and external audits, ensuring compliance with regulations.
Performed change analysis for quality system and product documentation release.
Reviewed SOPs, work instructions, and forms, providing revision recommendations.
Contributed to new product development by offering design assurance input.

QUALITY ASSURANCE LEAD

NANOSTRING TECHNOLOGIES

09.2018 - 11.2022

Collaborates with Quality Engineering and other departmental stakeholders to initiate new Corrective and Preventative Actions (CAPA).
Identifies and assigns CAPAs while constructing a closure plan.
Assigns action items to stakeholders, quality investigators, subject matter experts, and ensures completion of tracked items.
Reviews updated procedures and training records to ensure compliance.
Maintains the CAPA workflow within MasterControl and provides metrics to senior leadership.
Track step due dates and collaborates with owners to complete required actions in a timely manner.
Performs audits and trend analysis to verify effectivity of corrective actions.
Teams with Supplier Quality Engineers to document Supplier Corrective Action Reports (SCAR) within MasterControl.
Responsible for improving NanoString’s process for complaint handling and investigations.
Conducted a retrospective review of one thousand diagnostic complaints for remediation efforts to mitigate potential audit findings.
Creates and presents monthly metrics for Operational Excellence and Customer Experience teams.
Performed reviews of devices and applicable documentation to ensure country-specific requirements are met.
Assisted in developing a more effective tracking process for items needing review.
Responded to urgent requests from country representatives to provide supporting documentation for currently marketed devices.
Teamed with Corporate and International Regulatory staffs to provide support for new products and changes to existing products.
Collected data on device labels and implemented a more effective storage strategy to assist in identifying requested information.
Provides guidance to PMA and product registration procedures. Prepares device submissions.

QUALITY SPECIALIST III

PHILIPS MEDICAL - ECRA

08.2016 - 11.2017

Appointed Team Lead for Emergency Care and Resuscitation to lead 12 FTEs and Contractors
The first point of contact for post-market surveillance inquiries supporting teams worldwide.
Worked directly with 2 of the largest US customers (Fire Department of NYC and Pinellas County EMS) to better handle their service needs while also managing our service records.
Participated in onsite customer meetings to provide input from Quality Assurance to minimize device downtime and maximize first contact efforts.
Triaged and escalated Service Records to verify true complaints and review for Death and Serious Injuries.
Performed thorough failure investigations and documented all findings with TrackWise system.
Collaborated with Failure Analysis and Repair Centers to identify trends.
Contributed to Complaint Handling process improvement during the internal transition.
Interviewed, hired, and trained new employees and contractors to support the Quality Department transfer from Andover, MA to Bothell, WA.
Provided personnel metrics and KPI reports to senior leadership on a weekly basis.

TECHNICAL SUPPORT REPRESENTATIVE/QUALITY ASSOCIATE

FUJIFILM SONOSITE

07.2015 - 08.2016

Originated a cross-functional weekly team meeting to identify trends and to better understand common failures.
Converged with Engineering teams to discuss critical failures. Summarized all findings and sent a report to the Technical Support team to better equip them for failure analysis during customer interactions
Assisted with improving the design and templates of Customer Service Agreements to maximize time spent in preparing customer service requests. (Impacted Representative Ready Times)
Contributed to the implementation of Oracle redesign to better capture important data and ensured consistent and valuable data.
Initiated changes to ticket creation and common verbiage to better capture failure modes and assist Quality Assurance / Regulatory Affairs in identifying beneficial data.
Trained team members on the importance of captured data as the first line of communication between customers. (Reduced duplicated ticket creation and improved customer satisfaction)
Provided training on patient use cases and device failures to assist with Quality monitoring.

QUALITY COMPLAINTS TECHNICIAN

SPACELABS HEALTHCARE

04.2014 - 06.2015

Lead Retrospective Review Project (over 10,000 Complaint Records, Service Records, DHRs, Sales Orders).
Effectively managed several contractors and provided clear instructions to accomplish tasks.
Set goals and timelines for the review project and provided updates biweekly to senior leadership.
Through effective management completed the Retrospective Review Project 4 months ahead of schedule which saved on resources and allowed more time for audit preparations.
Organized collaborations between Regulatory Affairs, Quality Assurance, Global Product Support, Field Service, and Equipment Repair Center to better document service records and ensure consistency.
Contributed to improving the Complaint Handling Work Instructions and Quality Procedures by identifying outdated sections and revising current procedures for clarity.
Organized and cataloged Sales Order Inventory and Device History Records (DHRs) physically onsite to better manage records.
Created Digital Records and backups of all physical data for online review to be accessible online to improve time management and assist with audit preparations

Summary

Overview

Work History

HEAD OF REGULATORY

QUALITY ASSURANCE MANAGER

QUALITY ASSURANCE LEAD

QUALITY SPECIALIST III

TECHNICAL SUPPORT REPRESENTATIVE/QUALITY ASSOCIATE

QUALITY COMPLAINTS TECHNICIAN

Education

ISO 13485:2016 Lead Auditor (TPECS) -

Bachelor of Science - Information Technology, Networking

Skills

References

Personal Information

Work Availability

Timeline

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