Summary
Overview
Work History
Education
Skills
Affiliations
Languages
Timeline
Generic

Beth Foster

Margate,FL

Summary

Dynamic individual with hands-on experience in Regulatory Affairs in medical devices and talent for navigating challenges. Brings strong problem-solving skills and proactive approach to new tasks. Known for adaptability, creativity, and results-oriented mindset. Committed to making meaningful contributions and advancing organizational goals. Pursuing full-time role that presents professional challenges and leverages interpersonal skills, effective time management, and problem-solving expertise.

Overview

18
18
years of professional experience

Work History

Sr. Manager Regulatory Affairs

International Medical Industries
03.2025 - 06.2025
  • Lead Regulatory Affairs in EU submission of Class I sterile devices.
  • Provide support for Quality Systems.
  • Hosted MDSAP audit with 1 minor nonconformance.
  • Authored Pre-Submissions for devices.
  • Hosted Customer audits.
  • Provided regulatory strategy for Class I sterile devices.

Principal Regulatory Affairs Associate

Fresenius Medical Care
01.2024 - 02.2025
  • Lead Regulatory Affairs point of contact for water treatment systems.
  • Performed regulatory reviews of post clearance changes to water treatment system medical devices (Class II).
  • Authored Pre-Submissions (Q-Subs) and Traditional 510(k) Submission for Class II device.
  • Provided documentation review support for other team members.
  • Gathered, evaluated, organized, managed and collated information in varying formats.

Principal Regulatory Affairs Associate

Terumo Aortic
10.2020 - 09.2023
  • Analyzed approximately 100 product complaints and made recommendations regarding reportability for Class III endovascular stent-graft devices.
  • Submitted approximately 80 Medical Device Reports (MDR) per year for US and Medical Device Incident Reports (MIR/MDV) for European Union.
  • Reviewed and provided comments on adequacy of complaint investigation reports.
  • Tracked quality metrics for Medical Device Reporting.
  • Wrote or updated standard operating procedures, work instructions or policies.
  • Provided Regulatory Affairs expertise for preparation of first and second stage MDSAP audits.

Regulatory Affairs Manager

Cardinal Health
06.2017 - 09.2020
  • Performed timely preparation and submission of high-quality documentation for product registrations for Class II medical devices to FDA (1 traditional 510(k) and 1 special 510(k)), EU (MDD), TGA, Health Canada, Mexico, Canada, and Argentina.
  • Represented company in medical device industry during communications with global regulatory agencies.
  • Reviewed and provided comments on adequacy of product labeling and marketing information and took necessary steps to cure deficiencies.
  • Reviewed complaints, provided reportability determinations, submitted adverse event reports to regulatory authorities.
  • Participated in Internal Audits, Notified Body Audits (MDSAP), and Corporate Audits
  • Collaborated with cross-functional teams to ensure alignment on regulatory requirements and timelines.

Regulatory Affairs Manager II

Codman & Shurtleff, A Johnson & Johnson Company
02.2016 - 06.2017
  • Contract position
  • Evaluated emerging legislation and its potential impact on current products or future developments.
  • Recommended improvements to processes.
  • Assisted with regulatory product compliance initiatives such as Medical Device Directive (MDD) for neurovascular products.

Global Regulatory Affairs Manager

Nipro Diagnostics, Inc.
11.2010 - 11.2015
  • Trained team on initial review of complaints for possible Adverse Event/Medical Device Reports.
  • Submitted initial and follow-up Medical Device Reports (3500A) to FDA.
  • Managed team submissions of in-vitro medical devices and medical devices for Russia, Latin America, Australia, and China.
  • Represented company in medical device industry during communications with global regulatory agencies.
  • Executed 2 successful traditional and 1 special 510(k)s.
  • Executed 3 successful Technical Files/STED documents for EU submission, Health Canada, Russia, Latin America, Australia, and Pacific Rim countries.
  • Conducted thorough reviews of labeling content for accuracy and adherence to relevant regulations before submission to authorities, coordinated translations for product labeling and authored instructions for use for products.
  • Participated in Quality Audits for MDSAP, China SFDA.
  • Kept abreast of evolving industry trends, allowing the company to adapt quickly to changes in the regulatory landscape.
  • Enhanced regulatory compliance by developing and implementing effective policies and procedures.

Regulatory Affairs/Quality Assurance Manager/Supervisor

Home Diagnostics, Inc.
10.2007 - 10.2010
  • Reviewed complaints for reportability, submitted initial and follow-up Medical Device Reports (3500A) to FDA.
  • Aided in 2 successful traditional 510(k)s, executed 5 successful Technical Files/STED documents for EU submission, Health Canada, and Pacific Rim countries.
  • Represented company in medical device industry during communications with global regulatory agencies.
  • Conducted thorough reviews of labeling content for accuracy and adherence to relevant regulations before submission to authorities, coordinated translations for product labeling and authored instructions for use for products.
  • Participated in Quality Audits for FDA and EU.
  • Mentored junior staff members in best practices for regulatory affairs, contributing to overall team growth and development.
  • Created and maintained regulatory affairs procedures and processes to align with industry standards.
  • Coordinated with Quality Assurance in implementation of new electronic Quality System, ensuring minimal disruption to operations.
  • Oversaw transition to new quality management system, ensuring minimal disruption to operations.
  • Led successful project completions, coordinating effectively across multiple teams.

Education

Medical Technologist -

Carolinas Medical Center
Charlotte, NC
01.1986

BS - Zoology/Microbiology

North Carolina State University
Raleigh, NC
05.1985

Skills

  • Strategic planning
  • Operations management
  • Troubleshooting and problem resolution
  • Documentation and reporting
  • Cross-functional collaboration and team leadership
  • Attention to detail

Affiliations

  • Regulatory Affairs Professional Society
  • Medical Technologist, Specialist of Microbiology, American Society of Clinical Pathologists
  • Medical Technologist, American Society of Clinical Pathologists

Languages

English
Native or Bilingual

Timeline

Sr. Manager Regulatory Affairs

International Medical Industries
03.2025 - 06.2025

Principal Regulatory Affairs Associate

Fresenius Medical Care
01.2024 - 02.2025

Principal Regulatory Affairs Associate

Terumo Aortic
10.2020 - 09.2023

Regulatory Affairs Manager

Cardinal Health
06.2017 - 09.2020

Regulatory Affairs Manager II

Codman & Shurtleff, A Johnson & Johnson Company
02.2016 - 06.2017

Global Regulatory Affairs Manager

Nipro Diagnostics, Inc.
11.2010 - 11.2015

Regulatory Affairs/Quality Assurance Manager/Supervisor

Home Diagnostics, Inc.
10.2007 - 10.2010

Medical Technologist -

Carolinas Medical Center

BS - Zoology/Microbiology

North Carolina State University

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