Summary
Overview
Work History
Education
Skills
Certification
Affiliations
Volunteer Opportunity
Timeline
Generic

Nneoma Kalu

Concord,NC

Summary

Regulatory Affairs Specialist with demonstrated skills of working in the medical device industry. Experience includes US, Canada, EU, and rest of world (ROW) registrations, technical writing, labeling review, change impacts, audit support, customer advocacy, regulatory documentation, among many others. Combining Master of Science in Regulatory Science with regulatory experience to provide high quality deliverables in the medical device industry.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Regulatory Specialist II

Resolve Surgical Technologies
05.2023 - Current
  • Experience in regulatory strategy support and submission, compilation/writing for new submissions and renewals (US, EU, ROW), maintaining submissions/renewals, compliance with regulation and standard changes, market release process, assessing product/process changes and impacts, review of labeling (including package inserts and labels), product lifecycle support, technical file updates, clinical evaluation plan/report review, post market surveillance plan review, review of standard operating procedures/work instructions, internal audit support, UDI compliance, customer advocacy.

International Regulatory Affairs Associate

Teleflex Medical, Inc.
09.2021 - 06.2023
  • Experience in global regulatory requirements for new registrations, amendments, tenders, queries and renewals, maintaining submissions/renewals, assessing product/process changes and impacts, review of labeling (including IFUs and packaging labels), PMS/vigilance support.

Regulatory Affairs Assistant

Entegee, Inc.
10.2020 - 09.2021
  • Maintenance of registrations/approvals/clearances, labeling review for EU MDR and labeling address change impacts, project remediation, tracking and maintenance.

Communication Specialist

Navex Global
02.2020 - 10.2020
  • Data entry, customer calls, ethics hotline

Certified Lead Pharmacy Technician

CVS Caremark
03.2010 - 09.2018
  • Data entry, customer service, inventory management, prescription refills, pharmacy operations support

Education

M.S. in Regulatory Science, Drug, Biologics and Device Regulation, Drug and Biologics Discovery, Drug and Biologics Development, Clinical Research, Regulated Products in the Marketplace -

University of Maryland, Baltimore
Baltimore, MD

B.A. in Biology, Minor in Spanish -

State University of New York at Albany
Albany, NY

Skills

  • Project Management
  • Global Regulatory Compliance
  • Regulatory Submissions
  • Impact Assessment

Certification

  • RAPS, Regulatory Affairs Medical Device Certificate
  • Advanced Specialist - U.S. Regulatory Affairs Certificate from IRAET
  • Regulatory Affairs and Quality Assurance Training from Duke University of Medicine
  • Professional Development and Leadership Certification from the President's Student Leadership Institute at the University of Maryland, Baltimore

Affiliations

  • Regulatory Affairs Professional Society (RAPS)
  • North Carolina Regulatory Affairs Forum (NCRAF)
  • National Society for Leadership and Success (NSLS)

Volunteer Opportunity

Mentor - Pathway for Patient Health - Quality Science Education

Timeline

Regulatory Specialist II

Resolve Surgical Technologies
05.2023 - Current

International Regulatory Affairs Associate

Teleflex Medical, Inc.
09.2021 - 06.2023

Regulatory Affairs Assistant

Entegee, Inc.
10.2020 - 09.2021

Communication Specialist

Navex Global
02.2020 - 10.2020

Certified Lead Pharmacy Technician

CVS Caremark
03.2010 - 09.2018

M.S. in Regulatory Science, Drug, Biologics and Device Regulation, Drug and Biologics Discovery, Drug and Biologics Development, Clinical Research, Regulated Products in the Marketplace -

University of Maryland, Baltimore

B.A. in Biology, Minor in Spanish -

State University of New York at Albany

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Nneoma Kalu