Open To Work
Dr. Eyong Ebot, PhD
Principal Quality and Regulatory Consultant
Atlanta,GA
Summary
- Sr. Regulatory Affairs and Quality consultant/manager for medical devices and combination products with 20+ years of hands-on experience, including end-to-end ownership for FDAregulated medical devices, diagnostics, and combination devices.
- Leads enterprise design control transformation for medical device and software organizations under FDA, EU MDR, and ISO 13485, with a strong technical background in medical devices and combination products.
- Extensive experience authoring and managing 510(k), PMA, De Novo, IDE, and EU MDR/IVDR submissions for biological and tissue-based diagnostic products, ensuring alignment with FDA PMA regulations and guidance.
- As RA consultant and FDA 510(k) Third Party Final Reviewer, leads adherence to operational standards and regulatory requirements for Device ML/AI development, enhancing system stability and product quality in post-market support.
Overview
21
21
years of professional experience
5
5
Certification
Work History
Sr. Quality & Regulatory Affairs Consultant
Integra LifeSciences
01.2024 - 12.2025
- Managed global regulatory submissions and FDA communications, including preparation of responses to regulatory questions, deficiency requests, and post-approval change requirements.
- Reviewed and approved design control changes impacting 510(k), De novo, and PMA devices, supporting continued compliance, license renewals, and maintenance of FDA approvals.
- Implemented global regulatory strategy, ensuring alignment with evolving international standards and enabling efficient, compliant product commercialization across Class I-III medical devices.
- Led 510(k) submissions and key regulatory documentation while overseeing worldwide product compliance from design through distribution.
- Prepared and coordinated technical documentation for EU MDR/IVDR submission to notified bodies for CE Marking Approvals.
- Maintained compliance with IEC 62304, IEC 61010, MDR, MDSAP, ISO 13485, ISO 14971, and other relevant global regulations and standards.
- Assessed current-state design control processes across multiple product lines and identified compliance gaps, redundancies, and inefficiencies within DHF, DMR, and risk management files.
- Led the development and lifecycle management of Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), PMCF Evaluation Reports (PMCFERs), and Summary of Safety and Clinical Performance (SSCPs) in compliance with EU MDR and aligned to global standards.
- Provided end-to-end risk management and V&V oversight throughout the product lifecycle, ensuring alignment with FDA PMA expectations and cross-functional regulatory readiness.
- Ensured that CMC regulatory strategies enable potential accelerated product development pathways. Authored/reviewed CMC documentation for submission, applying agreed CMC global regulatory strategies, current regulatory trends, and post-marketing guidelines.
Sr. Quality & Regulatory Affairs Consultant
Baxter International
02.2023 - 12.2024
- Managed global registrations and licenses across major markets, including the US, EU, Canada, China, Brazil, South Korea, Japan, LATAM, and Australia.
- Guided development of devices with embedded software, ensuring safety, cybersecurity, and risk management per IEC 62304, IEC 82304, ISO 14971, and related standards.
- Served as primary liaison with regulatory authorities worldwide, strengthening government and agency relationships.
- Led design control and supported risk management and V&V oversight per the requirements of ISO 13485/FDA QSR design controls, ISO 14971 risk management, IEC 62366 usability engineering, and IEC 62304/AI-ML integration in software development.
- Led end-to-end regulatory strategy, authoring, and submission execution for all complex 510(k), De novo, PMA, and combination products, ensuring full compliance with FDA regulations, guidance, and submission standards.
- Provided regulatory insights and action plans to cross-functional teams to ensure regulatory compliance, with particular focus on In Vitro Diagnostic Regulation (EU) 2017/745/746 MDR/IVDR, FDA 21 CFR 820, CMDR SOR 98-292, ISO 13485:2016, IMDRF and other applicable International Medical Device Regulations. Contribute to Internal and external training of stakeholders.
- Led systematic literature reviews, data extraction/analysis, and critical appraisal to support clinical evaluations and regulatory submissions.
- Develops and leads CMC regulatory strategy for biologics and pharmaceuticals, balancing innovation, business benefits, and regulatory compliance.
- Developed and implemented regulatory CMC strategy and submission plans to support global pivotal clinical trials, including authority meetings, authoring, and submissions of combination products with the FDA and other agencies.
- Reviewed and assessed regulatory pathways and clinical plans for GCP. Formulated and led as SME on Clinical Evaluation Plan (CEP), Clinical Data Analysis, Risk-Benefit Analysis, Post-Market Surveillance (PMS) & Post-Market Clinical Follow-up (PMCF).
Sr. Quality & Regulatory Affairs Consultant
ZOLL Medical Corporation
01.2022 - 01.2023
- Implemented standardized global design control frameworks aligned with FDA 21 CFR 820 and ISO 13485 and established traceability models linking user needs → design inputs → verification → validation → risk controls → release.
- Authored, drafted, compiled, and supported submission of complete 510(k), De novo, and PMA in accordance with FDA regulations and guidance, partnering closely with cross-functional stakeholders to ensure submission accuracy, completeness, and on-time delivery.
- Authors Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs), including the clinical sections of any/all regulatory authority requests.
- Authors Post-Market Surveillance Plans, Post-Market Clinical Follow-Up Plans, Post-Market Surveillance Reports, Post-Market Clinical Follow-Up Reports, Periodic Safety Update Reports, and Summary of Safety and Clinical Performance reports.
- Successfully managed and supported an original PMA submission (180-day review) for the LifeVest Wearable Defibrillator, authoring and compiling PMA documentation in collaboration with R&D, Clinical, Quality, Software, and Manufacturing teams, resulting in FDA approval within six months.
- Collaborated cross-functionally with R&D, Quality, Clinical Operations, Software Engineering, Manufacturing, and Marketing to gather, review, and finalize PMA-required documentation.
Sr. Global Regulatory Affairs and Quality Assurance Engineer
Philips Healthcare
Pittsburgh
07.2008 - 12.2021
- Elevated QMS performance in alignment with FDA 21 CFR 820, ISO 13485, MDSAP, and GxP requirements; led strategic transition to EU MDR.
- Support development and execution of design control processes for medical device products to meet MDR and other global requirements.
- Oversaw supplier qualification and internal/external audits to ensure GMP compliance and ethical sourcing.
- Streamlined global regulatory pathways to accelerate market access in regions such as South Korea (KGMP), Indonesia, the Philippines, and China.
- Led audit readiness, sustained global certifications, and mentored regulatory teams to foster a culture of continuous improvement.
- Standardized V&V documentation practices to reduce review cycles and regulatory deficiencies.
- Integrated ISO 14971-compliant risk management into design lifecycle documentation.
- Supported R&D, Quality, Regulatory Affairs, Manufacturing, and NPI teams to embed compliant design practices.
- Facilitated cross-functional working sessions to align stakeholders on standardized documentation models.
- Supported NPI programs through stage-gate integration of quality and regulatory checkpoints.
- Served as Regulatory Affairs Subject Matter Expert (SME) supporting 510(k), De novo, and PMA-regulated medical devices, with direct involvement in high-risk and recalled product remediation aligned with FDA expectations.
- Authored, compiled, reviewed, and supported 510k and PMA-related submission modules, including administrative, clinical, labeling, and risk management documentation, ensuring compliance with FDA regulations and guidance.
- Led regulatory strategy and execution for complex submissions, renewals, and changes impacting PMA-approved products, including assessment of design and engineering changes requiring FDA notification or approval.
- Pittsburgh, USA
Lead Project Engineer
Hewlett-Packard
Alpharetta
03.2005 - 06.2008
- I identified risks and issues in business processes and systems; wrote, scheduled, planned, managed, and executed process performance qualifications/verifications and process validations in compliance with product requirements.
- Coordinated and collaborated with cross-functional roles, including Research and Development, Quality.
- Developed, recommended, and documented quality assurance activities on deviations and CAPAs; investigated and helped resolve customer complaints and non-conformance issues while ensuring ongoing compliance with quality and regulatory requirements.
- Optimized engineering change control workflows to ensure robust impact assessment and documentation updates.
- Designed KPI dashboards tracking DHF completeness, V&V coverage, risk closure rates, and change cycle time.
- Alpharetta, USA
Education
Postdoctoral - Digital Health and Data Science
01.2024
Ph.D. - Engineering Management
01.2020
MSc. - Quality Engineering-Quality Assurance
01.2012
BSc. - Biomedical Engineering
01.2004
Skills
- Managing regulatory operations
- Authoring regulatory submissions
- Compiling regulatory submissions
- Conducting gap analyses
- Developing action plans
- Supporting QMS audit readiness
- Supporting inspection readiness
- Project Management
- Multitasking
- Timelines
- Prioritization
- Cross-Functional Communication
- ERP Tools
- Agile
- Jira
- Veeva Vault RIM
- Jama
- Polarion
- SAP
- MS Office
- SharePoint
Certification
- EU MDR/IVDR regulatory affairs
- Certified ISO 13485 & 9001 Lead Auditor
- FDA AI/ML SME
- IEC 62304 - Software Development
- Certified ISO 14971 Risk Management
- Certified Six Sigma MBB
- Certified Quality Engineer (CQE)
- Regulatory Affairs Certification (RAC)
Affiliations
- Regulatory Affairs Professionals Society (RAPS)
- American Society for Quality (ASQ) Biomedical Division
- Advanced Medical Technology Association (AdvaMed)
Personal Information
Title: Sr. Quality & Regulatory Affairs Consultant/Specialist/Managing Director
Accomplishments
- Author of “Med-Chains,” published in E&E Medicals in 2021.
- Resolved product issue through consumer testing.
- Collaborated with a team of 15 Engineers in the development of an FDA PMA Project approved in Record Time
- Supervised a team of 20 staff members.
- Documented and resolved the Recall of Dream Station Products, which led to redesign and implementation.
- Collaborated with the team of the EU MDR Project in the CE MARK Approval
- Development of multiple Wellness apps.
Work Preference
Work Type
Full TimePart TimeContract WorkGig WorkLocation Preference
RemoteHybridTimeline
Sr. Quality & Regulatory Affairs Consultant - Integra LifeSciences
01.2024 - 12.2025
Sr. Quality & Regulatory Affairs Consultant - Baxter International
02.2023 - 12.2024
Sr. Quality & Regulatory Affairs Consultant - ZOLL Medical Corporation
01.2022 - 01.2023
Sr. Global Regulatory Affairs and Quality Assurance Engineer - Philips Healthcare
07.2008 - 12.2021
Lead Project Engineer - Hewlett-Packard
03.2005 - 06.2008
Harvard University - Postdoctoral, Digital Health and Data Science
Walden University - Ph.D., Engineering Management
Southern Polytechnic State University - MSc., Quality Engineering-Quality Assurance
University of Applied Sciences - BSc., Biomedical Engineering