Overview
Work History
Education
Skills
Certification
Timeline
Generic

Paige Johnson

Belmont,MA

Overview

4
4
years of professional experience
1
1
Certification

Work History

Regulatory Affairs Specialist

ZOLL Medical Corporation
02.2022 - Current
  • Led regulatory activities for a Class II (EU IIb) medical device (AutoPulse™) and supported global regulatory efforts for Class III public access AEDs
  • Prepared and submitted regulatory documents, including 510(k) premarket notifications (Traditional 510(k), 510(k) Letter to File) and PMA supplements (30 Day/CMMI, PMA Annual Reports), ensuring FDA compliance
  • Assisted in the preparation and submission of EU MDD/MDR regulatory documents, such as Technical Files, Design Dossiers, and Clinical Evaluation Reports
  • Managed new license applications and license renewal submissions for various global markets (e.g., Health Canada, APAC, Brazil, Saudi Arabia)
  • Supported regulatory dispositioning of product changes, including engineering, design, and labeling changes, to ensure compliance
  • Developed regulatory strategies for Global Product Management and Marketing teams, identifying risks and growth opportunities for new product development
  • Monitored global regulatory changes, communicating updates to internal stakeholders and ensuring organization-wide compliance
  • Participated in internal and external audits, providing regulatory documents and explanations as required
  • Maintained accurate and up-to-date information for multiple product lines within two Quality Management Systems.

Regulatory Coordinator II

Dana Farber Cancer Institute, DFCI
06.2021 - 02.2022
  • Organized and led research meetings with Principal Investigator and external institutes to discuss trial status, regulatory information, and patient participant updates
  • Facilitated communication between DFCI study team, sponsor, and external parties regarding study status, critical safety issues, and protocol, consent, and IDB amendments
  • Reported major trial changes and routine Annual Reports to FDA as required
  • Assisted in preparing for DFCI internal IRB audits
  • Successfully fulfilled all responsibilities of Regulatory Coordinator I role independently, while taking on these additional duties.

Regulatory Coordinator I

Dana Farber Cancer Institute, DFCI
11.2019 - 06.2021
  • Coordinated protocol submissions and maintained electronic trial master files (TMF) for 12+ breast oncology IND clinical trials, ensuring compliance with DFCI policies, FDA regulations, and Good Clinical Practice (GCP) guidelines
  • Collected and managed study documents for over 20 external study sites, including personnel changes, investigator changes, and adverse events, for each trial
  • Tracked and managed new protocols in the study start-up process, ensuring compliance with local and federal benchmarks.

Education

Bachelors - Communication

University of Massachusetts Amherst
05.2018

Skills

  • Global Regulatory Compliance (FDA Regulations (21 CFR), EU MDD/MDR, ISO standards)
  • Regulatory Submissions
  • Cross-Functional Collaboration (R&D, Quality Assurance, Marketing, Product Management)
  • Documentation Tracking and Quality Management Systems (QMS)

Certification

  • Implementing EU MDR
  • CAPA Lead Certification
  • FDA Premarket Approval (PMA) and Investigational Device Exemption (IDE) Strategy

Timeline

Regulatory Affairs Specialist

ZOLL Medical Corporation
02.2022 - Current

Regulatory Coordinator II

Dana Farber Cancer Institute, DFCI
06.2021 - 02.2022

Regulatory Coordinator I

Dana Farber Cancer Institute, DFCI
11.2019 - 06.2021

Bachelors - Communication

University of Massachusetts Amherst

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