Regulatory Affairs Product Development

Location:

Posted:

April 09, 2025

Resume:

SUMMARY:

Seeking Regulatory Leadership Position. 20 years regulatory leadership and 20 years R&D software engineering. Skilled at new product development, product classification, requirements determination, regulatory intelligence, executing regulatory compliance & submission strategies for novel complex products. Recent Certifications in Digital Health, SaMD, AI, and Cybersecurity

CAREER STATEMENT

“Life long learner passionate about advancing systems which help people be active contributing members of society through the use of technology, standards, quality principles, and regulatory framework”

PROFESSINAL EXPERIENCE

Philips Health Care 1/27/2025- Present

Senior Regulatory Affairs Specialist Ultrasound Division

Sustaining engineering change assessments – performed change assessments according to US, EU, CA and OUS regulatory requirements and internal procedures. Pulled, created, and filed reports in Windchill Product Documentation Library

Codington Research Development & Advocacy, LLC

Founder / Principal. Part time, short term regulatory consulting projects.

Optimal Acuity Holdings Inc – January 2025

Wrote a regulatory opinion letter about manufacturer responsibilities in Canada when a single use device license is inactivated.

Ken Block Consulting May 2024

Drafted a US FDA 510(k) submission for an enteral infusion pump so the client could meet their promised timelines

Becton Dickenson (BD) 9/4/2018 – 12/14/2022

Senior Staff Regulatory Affairs Specialist

Regulatory lead on the cross functional new product development team. The Libertas™ is the device constituent of drug-device combination product containing a complex container closure system and many novel automated functions. It has a ‘smart’ as well as a mechanical embodiment.

Software in Medical Device (SiMD) New Product Development

Concept Phase - Regulatory lead for two BD Digital Innovation Team Projects providing comprehensive regulatory competitive product research, analysis, and discussion on potential regulatory submission pathways.

Feasibility Phase – Wearable Injector Regulatory lead on cross functional team. Authored regulatory strategy (US, EU, Japan) identifying submission route, requirements, and competitive market research.

Device Constituent of a Combination Product

Design Phase - Regulatory lead on cross functional team developing a large volume wearable injector with a novel fluid transfer system. Accomplishments:

Early Development Meeting with US FDA – co-authored submission packet, trained team, presented to FDA, debriefed leadership and customer

Regulatory Strategy (US, EU) – Authored comprehensive regulatory strategy. Identified top level country specific regulatory submissions strategy for clinical and commercial product release. Provided position statements on relevant regulatory topics including labeling, sterilization, biocompatibility, materials of concern, safety assurance case. Provided regulatory competitive product research.

Regulatory Intelligence – Led regulatory impact assessments of changing standards to BD Pharmaceutical Solutions to BDs portfolio of drug-delivery devices.

International Standards Development AAMI ISO TC 84 led the proactive impact assessments of draft standards with the cross functional product development team, identified program gaps, collected feedback for discussion with International Standards Committee.

Research & Development – collaborated closely with R&D in the following areas:

-Classification & Requirements Analysis – Performed a formal detailed robust systematic retrospective review of product classification and performance requirements for US and EU markets which included a clause-by-clause review of 23 harmonized standards and identification of product performance, test method, procedural, contractual among other requirements which were formally documented in a compliance plan.

-Requirements Gap Analysis, Remediation Planning, & Execution – Identified product performance gaps between requirements and Design Input Specifications. Led the review and cross functional alignment on gaps and next steps.

-Commercial Product Release Quality Compliance Plan – Authored & led the commercial product compliance plan, which identified requirements for commercialization.

-New standards - SME and collaborator with R&D in the understanding and implementation of new requirements regarding injector classification, essential performance, safety assurance case and sterile fluid transfer. Resulted in new internal procedures and updates to design documentation. (ISO 11608-6:2022 Needle based injection systems for on body injectors)

-Design Reviews and Design Documentation – Regulatory lead responsible for regulatory approval of design documentation. Presented regulatory summaries at design review meetings to executive leadership.

-Submissions Planning – identified required internal reports and created a tracker to ensure timely assembly of US FDA drug master file and EU MDR General Safety and Performance Requirements (GSPR)

Quality – Ongoing collaboration with Quality on the following topics

-Risk Management – Regulatory member of risk management team responsible for reviewing, approving and ensuring risk management documentation met new and changing regulatory requirements.

-Supplier Management – Regulatory contributor, reviewer and approver of supplier contracts. Ensured regulatory requirements were appropriately identified in supplier templates and contracts.

-Clinical Product Release Benefit Risk Assessment (BRA) – Regulatory contributor and approver of the BRA which identified gaps between the regulatory requirements and clinical product which needed to be addressed prior to release of the device for customer drug-device clinical trials.

Medical & Clinical Affairs –Regulatory contributor, reviewer and approver of directions for use, human factors test plans, testing proposals, and test reports.

Claims Development & Ad Promo Reviews – Regulatory lead collaborating with marketing in the development and approval of marketing claims, labeling and promo material for a novel pre-commercial product. Determined minimal required labeling for product to be used in pharma partner clinical trials.

Customer Engagement – Regulatory lead on cross functional team responsible for coordination with pharma partners

-B2B Customer Agreements – Regulatory reviewer

-Competitive Analysis – Performed competitive regulatory product & requirements analysis within US and OUS regulatory systems; summarized results, and presented to cross functional teams who leveraged results.

-Collaboration – Regulatory business to business collaboration on various topics including but not limited to classification, essential performance requirements, safety assurance case, fluid transfer microbial ingress.

-IDE / Drug master file - planning of device content in accordance with US FDA IDE submission format for customer’s IND and BLA submissions.

Terumo Medical Corporation 12/2016 – 6/14/2018

Senior Regulatory Affairs Specialist

Lead US/Canada Regulatory consultant for multiple Terumo businesses (TPS, TMP) and multiple manufacturing plants (US, Europe, Philippines, China, Japan) spanning cardiology, general hospital needles, syringes, kits, combination products, and prefilled syringes.

New Product Development – Feasibility Phase for intradermal injector – Regulatory lead responsible for leading and hosting Japan R&D team. Coauthored early development meeting with US FDA.

Sustaining Product Regulatory

Product Changes- Regulatory lead for multiple products being manufactured in US, Europe, Philippines, China, Japan met regulatory requirements. Reviewed proposed design changes, corresponded with factory and technical staff, prepared internal ‘non-filing’ justifications for US FDA 510(k) premarket approval and filed Health Canada License Amendments as needed.

Regulatory Intelligence – Authored a monthly regulatory intelligence report highlight upcoming regulatory changes for US product lines.

Promotional Review Awards – provided regulatory review of IFU, labels and promotional materials in Veeva Vault. Recipient of team awards for promotional review and audit preparations

Submissions – Authored and maintained Health Canada License Amendment Applications.

Light Age, Inc. – Advanced Laser Systems 2/2004 – 12/2016

Director Global Regulatory Affairs

Company Regulatory & Quality Lead for high powered laser systems controlled by software and electronics reporting to CEO

Software (SiMD) - IEC 62304: Led software classification, construction of design documentation (architecture, requirements), risk assessment (ISO 14971), verification and validation activities, demonstrating design met requirements and demonstrating software met user needs thus proving applicable sections of IEC 62304 were met leading to FDA, CE Certification and Health Canada Licensing.

Medical Electrical Equipment - IEC 60601: Led the finding, qualification, and engagement of an independent 3rd party Safety Testing to applicable electrical & laser system standards. Negotiated contract terms, scheduling. As company corresponded communicated and resolved requests for additional information with internal stakeholders, leading to report acceptance and various US and international marketing clearances.

R&D – Regulatory lead for new ophthalmic laser - including independent laboratory testing, requirements analysis.

Pre-Clinical Study – Co-authored small pre-clinical study which received IRB approval.

Product Design Documentation – Established product Technical Files. Reviewed and approved all product design documentation including product risk management, systems requirements, V&V reports.

Reviewed and responded to US FDA FOI requests

Laboratory Testing - Led National Accredited Laboratory Testing of medical lasers with software

Risk – Led risk assessment teams for existing and developing products

US FDA 510(k) & International Submissions & Marketing Clearances- Global Regulatory submissions Leadership with expertise in requirements analysis, strategy development, design dossier pre-submission coordination, creation, tracking; post-submission correspondence

US FDA 510(k) Clearances – Authored 3 submissions

US FDA Certificates to Foreign Government – Authored & filed numerous submissions leading to timely certification

CE Marking – Established the company’s first successful CE Certification under MDD, Full Quality System Audit

Global Registrations – Established 17 global registrations

Compliance Programs – Established quality system, medical device, and technology compliance.

Established ISO 9001 Quality System Certification for scientific & medical laser systems development

Established ISO 14971 Quality System Certification & led product risk team

Established ISO 13485 Medical Device Quality System Certification

Export Compliance - Established US Export Administrations Regulations (EAR) compliance program ensuring export of laser system technology was in accordance with US regulations.

Due Diligence – Identified and provided Quality and Regulatory due diligence documentation needed for funding

Quality Systems Management Representative

Responsible for all interactions with Health Authorities and Test Houses.

Prepared and submit management reports relating to internal systems, compliance and incidents

Maintained accreditations, test certifications, product and marketing licenses

Identified & maintained library of requirements & resources (legislative, regulatory, compliance, import/export)

Ensured company policies, procedures, and work instructions are documented in a clear, simple and concise manner.

Business development – provide QA documentation and ensure B2B contracts & tenders meet regulatory requirements.

Training – Authored company policies and trained personnel

Import/Export Regulatory Compliance – Resolved gnarly problems preventing timely import/export of product through collaboration with company import broker, US FDA JFK Field Office, and our local congressional office.

Interactions

Health Authorities - Direct lead interaction with auditors, NBs, government agencies leading to marketing clearances.

3rd Party Safety Certification Testing Programs

Distributors – Instrumental in ensuring international distributor agreements met relevant regulatory requirements.

All Departments – worked closely with executives & technical teams including R&D, Software Engineering, Electrical Engineering, Medical Affairs, Manufacturing, Purchasing, Accounting.

Direct Reports – managed technical deliverables of up to 4 Quality Systems support personnel.

AT&T Labs 1983 - 2003

Member Technical Staff

Computer Information System

Software Engineer within ISO 9001 QMS.

oProgramming Languages – C++, LISP, PL/1, Assembler

oISO Computer Systems Engineering Documentation - Authored over 100 complex computer systems engineering documents spanning: computer systems architecture, requirements analysis; systems operation and administration manuals, installation manuals, service manuals; systems integration & interoperability plans, migration, and disaster recovery plans and patch installation scripts;

oStandard Operating Environment Development - Evaluated computer languages, network devices, browsers and made formal written recommendations for incorporation into corporate standard operating environment.

oTechnical Support - Recipient of the UNIX tech support award.

Usability Engineering Leadership / Section 508 Compliance /Section 255 Telcom Act / W3C WCAG

oBusiness Case – Authored business case and received funding ($250,000) to promote Innovation through Accessibility Engineering to address Section 508 of the Workforce Investment Act across AT&T Businesses.

oPolicy Leadership - Facilitated corporate wide adoption of internal policies and technical standards to implement the technical framework within the World Wide Web Consortium which also allowed information to be viewed on small hand-held devices. Reported to Executive VP of AT&T Labs, worked at a working level with Law & Government Affairs and all business units; managed technical teams with 6 members

oImpact Analysis, Compliance Evaluations & Remediation Plans - Performed legal impact analysis of regulations, compliance evaluations; remediation plans for marketing materials of AT&T WorldNet and AT&T Wireless.

oTechnical standards – utilized the technical standards of W3C and CSS to create role model accessible web sites.

oInvited presenter to prestigious forums: Temple University, AT&T: User Experience Forum, Technology & Design Lab, Intranet Steering Committee. Published

ACHIEVEMENTS – LEGAL PRECEDENCE

Engaged in Complex Civil Litigation, resulting in a Court of Appeals interpretation of Special Education Law, which was upheld by the third Circuit Court and later incorporated into NJ Administrative Code in the area of Free Appropriate Education and Least Restrictive Environment. Not only did this 2000 ruling (TR & EMR on behalf of NR vs Kingwood Board of Education) help my son, it is still cited today and still helping preschoolers receive a free inclusive education with the necessary supports and services in their neighborhood school.

RELEVANT EDUCATION & TRAINING

B.S. Degree, Ramapo College of NJ 1980

Double Major Environmental Science & Philosophy

Master Degree Program Credits from various universities in: 1986 - 2004

Computer science (1986) Stevens Institute of Technology

Accessibility (1999), California State University, Northridge

Project management (2003) AT&T School of Business in cooperation with Stevens Institute

Special education (2004) Lehigh University

Management & Computer Science

AT&T School of Business 1985-2003

Chubb Institute for Computer Technology 1982

Certifications, CEU and Corporate Trainings

Artificial Intelligence (AI) Ninja White Belt Certification April 2025

Introduction to Generative AI March 2025

What is Generative AI?

What is Copilot? Get started with Microsoft’s Everyday AI Companion

Introduction to Large Language Models

Introduction to Artificial Intelligence

Investing in Human Skills in the Age of AI

Generative AI for Healthcare

Integrating AI into Business Processes

AI Prompting March 2025

Introduction to Prompt Engineering for Generative AI

Advanced Prompt Engineering

Fundamentals of Prompt Engineering

Responsible AI Principles and Regulations April 2025

Navigating the EU AI Act

Foundations of Responsible AI

Financials April 2025

Understanding the Cost of Generative AI Models

How to Choose The Right AI Foundation Model

Generative AI Tools at Philips April 2025

BlueBot

Philips AI Chat

MS 365 Copilot

Monigotcha (hpmbot)

Security Management Framework

Philips HealthCare Ultrasound Division - Internal Trainings

US Regulatory Landscape & Considerations – Radiology Software March 2025

US FDA Device Misclassification and Remediation Lessons Learned April 2025

Introduction of the Responsibility AI Office April 2025

FDA Guidance Document Reviews 2025

Marketing Submission Recommendations for Predetermined Change Control Plan

for AI Enabled Device Software Functions 2025

for AI/ML Enabled Device Software Functions 2025

Digital Health – US FDA CDRH

Artificial Intelligence: A Regulatory Perspective (RAPS) 2023

Digital Health Center of Excellence of US FDA CDRH 2023

Changes to Existing Medical Software Policies

Resulting from Section 3060 of the 21st Century Cures Act 2023

Digital Health Precertification Pilot Program 2023

Design Considerations &Premarket Submission Recommendations Interoperable Medical Devices 2023

Content of Premarket Submissions for Device Software Functions, Final Guidance 2023

Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices 2023

SaMD

SaMD, Software as a Medical Device, 2-day in person course by MedSec & US FDA 2023

SaMD Product Development: Addressing Challenges through Early Integration of

Regulatory, Quality and Clinical Data Integration 2023

Digital Health Center of Excellence (FDA presentation to Boston RAPS chapter) 2023

SBOM – Software Bill of Materials. Webinar by MedSec 2023

Cybersecurity Coursework

Cybersecurity Workshop, RAPS 2-day in person course by MedSec and US FDA 2023

Cybersecurity in Medical Devices: QMS Considerations in Premarket Submissions 2023

Post market Management of Cybersecurity in Medical Devices Final Guidance 2023

Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act, Draft Guidance 2023

Regulatory Intelligence - RAPS 2 Day Regulatory Intelligence Summit 2025

Start & Grow a Successful Regulatory Intelligence Program 2025

Leveraging Technology for Efficient and Strategic Regulatory Intelligence 2025

Use of AI / ML to Enhance Regulatory Intelligence 2025

Global Regulatory Trends 2025

Regulatory Intelligence Strategy 2025

Combination Products / Prefilled Syringes

RAPS Conference - Combination Product Summit 2024

SIMI Prefilled Syringes Conference - Paradigm of digital health and connectivity 2017

Design Controls, Risk Management & Large Scale Product Testing

Preparing a large-scale testing project - Nemko Web Direct Seminars – 2016

Medical Devices: Definition & Lifecycle 2015

Design Control and Risk Management– Oriel Stat-A-Matrix Certified 2015

Regulatory Submissions – Product Testing

Project Management for Regulatory Professional 2015

Intro to RA in the US and Canada 2015

Medical Device Product Submission (US, Canada, Europe) 2015

ISO 13485 Quality Systems - Lead Auditor Training - Oriel Stat-A-Matrix 2014

COMMUNITY INVOLVEMENT

Member Hunterdon Hiking Club 2004-Present

Core Member – Limitless, a BD Disability Business Resource Group 2018-2020

Somerset County Board of Elections – Poll Worker 2016-2018

VP Accessibility Engineering - AT&T’s Disability Business Resource Group 1997-2003

Board of Directors - NJ Coalition for Rehabilitative Technology (NJ CART) 2000-2002

Board of Directors - NJ Regional Early Intervention Program 1998-1999

Cub Scout Leader - Den 251, Kingwood Township, NJ 1995-1998

Basic Rights Workshop of NJ Parents Advocacy Network (SPAN) 1995

Project Take Charge (40 hours) NJ Dept of Developmental Disabilities. 2000

Candidate – Kingwood Township Board of Education 1994-1994

PERSONAL ATTRIBUTES & SKILLS

Personal Attributes

Energetic Tenacious Technical Collaborator

Inquisitive Mentoring skills Team Player Friendly, Outgoing

Innovator High Performing Unassuming Passionate

Skills

Technical Standards

Software

IEC 62304

IEC 60601-1-4

Medical Electrical Systems

IEC 60601-1

IEC 60601-1-1

IEC 60601-1-2

IEC 60601-2-22

Risk

ISO 14971

Quality Systems

21 CFR 820

ISO 13485

ISO 9001

Laser Systems

21 CFR 1040

IEC 60825

EN 1551

US Export Administration Regulations

Combination Products

21 CFR 4

Needle Based Injection Systems

ISO 11608 Series

ISO 11040 Series

ISO 11607 Series

ISO 23908 Sharps Injury Protection

Biological Evaluation

ISO 10993 Series

Sustainability

RoHS

WEEE

California Proposition 65

REACH

Persistent Organic Pollutants

Packaging & Sterilization

ISO 11607 series

ISO 11135-1

ISO 11737-1

Details of course certifications

Artificial Intelligence (AI) Ninja White Belt Certification April 2025

Introduction to Generative AI March 2025

What is Generative AI? Feb 2025

What is Copilot? Get started with Microsoft’s Everyday AI Companion March 2025

Introduction to Large Language Models March 2025

Introduction to Artificial Intelligence March 2025

Investing in Human Skills in the Age of AI March 2025

Generative AI for Healthcare March 2025

Integrating AI into Business Processes March 2025

AI Prompting March 2025

Introduction to Prompt Engineering for Generative AI April 2025

Advanced Prompt Engineering April 2025

Fundamentals of Prompt Engineering April 2025

Responsible AI Principles and Regulations April 2025

Navigating the EU AI Act April 2025

Foundations of Responsible AI April 2025