Summary
Overview
Work History
Education
Skills
Affiliations
Certification
Timeline
Generic

Claire Arakaki

Quality and Regulatory Specialist
Lowell,Massachusetts

Summary

Regulatory Affairs Managers with 4+ years of supporting compliance management experience. Works well with consulting cross-functional teams on minimizing regulatory risk. Goes above and beyond to manage priorities and problem-solve with quick turn-around expectation.

Overview

25
25
years of professional experience
1
1
Certification

Work History

Regulatory Affairs Manager

Philips Healthcare
07.2019 - Current
  • Led Regulatory teams of 7 members for regulatory product compliance for Patient Monitoring devices.
  • Recommended improvements to quality system processes.
  • Assisted in the creation of product technical file packages for global product compliance certifications of patient monitoring products.
  • Provided strategics regulatory submission guidance to regulatory and development teams.

QA& Regulatory Engineer

Philips Healthcare
07.2007 - 05.2019
  • Created global regulatory submissions for medical devices Telemety, Central Stations and associated accessories.
  • Provide guidance to new acquisition businesses for technical and quality system compliance.
  • Assist with regulatory, compliance, and quality System matters to suppliers.
  • Provide compliance, regulatory, quality standards guidance to various Patient Monitoring project groups
  • Provide guidance on various safety standards including non-medical products. e.g Lithium Batteries and Information Technology Equipment.
  • Host audits for ISO 13485 and various country inspections.
  • Assist with submission of radio devices for FCC, IC, and rest for world RF certifications
  • Assist with OEM vendor issues and review specifications for compliance and quality requirements
  • Conduct internal Audits
  • Authored 510(k)s for US submission.

Project Engineer/Auditor

Underwriters Laboratories
01.1999 - 01.2007
  • Quality System Auditor for Notified Body
  • Quality System Auditor for ISO 9001, 13485
  • Safety Compliance testing of Medical Devices, Information Technology Equipment, Laboratory Equipment, Test and Measurement Equipment
  • 510(k) 3rd party reviewer

Education

BS - Biomedical Engineer

Milwaukee School of Engineering
Milwaukee, WI

BA - Physical Anthropology

University of Hawaii At Manoa
Honolulu, HI

Skills

  • Regulatory Compliance and Documentation
  • Quality System Auditing
  • Electrical Safety testing

Affiliations

PAE – Professional Administrator, Electrical in the State of Washington EIT – Engineer in Training Certificate in the State of Oregon. CQE – Certified Quality Engineer from ASQ Paralegal certificate from Boston University PROFESSIONAL MEMBERSHIPS IEEE – General IEEE – Product Safety Engineering Society ASQ- General Languages Studied Japanese French Korean Russian Page 4 of 4

Certification

ASQ-CQE certified

Received ISO 17025 training to audit test labs
Obtained journeyman electrician license in State of Washington

Timeline

Regulatory Affairs Manager

Philips Healthcare
07.2019 - Current

QA& Regulatory Engineer

Philips Healthcare
07.2007 - 05.2019

Project Engineer/Auditor

Underwriters Laboratories
01.1999 - 01.2007

BS - Biomedical Engineer

Milwaukee School of Engineering

BA - Physical Anthropology

University of Hawaii At Manoa

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Claire ArakakiQuality and Regulatory Specialist