Darren Demerritt

Sr Director Quality & Regulatory Compliance, North America @Arjo

Everett, WA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Sep 2021 — Present

Sr Director Quality & Regulatory Compliance, North America @Arjo

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Seattle, WA, US

Responsible for all Quality and Regulatory Compliance Activities for North American Sales and Service Organizations which includes QRC responsibilities over all rental and service operations along with Arjo\'s single use medical device reprocessing facility.

EDUCATION

2022

Eastern Washington University

Graduate Certificate , Health Services Administration

2005

Eastern Washington University

Bachelor's degree, Marketing

2022

Eastern Washington University

Master of Business Administration - MBA

2005

Eastern Washington University

Bachelor's degree, Operations Management and Supervision

SKILLS

R&DMdrsFmeaProduct DevelopmentU.s. Food and Drug Administration (Fda)Regulatory RequirementsCross-Functional Team LeadershipIso 14971IsoFdaProcess ImprovementRegulatory Affairs21 CfrQuality AssuranceRoot Cause AnalysisDesign ControlIso StandardsQuality SystemV&VProject ManagementMedical DevicesManagementCapaIso 13485Corrective and Preventive Action (Capa)GmpValidationSix SigmaProduct Launch

ABOUT DARREN DEMERRITT

As a professional regulatory affairs and quality assurance leader with a rich background full of accomplishments in the regulatory and quality field, I have built, implemented and managed regulatory and quality systems that are necessary to ensure compliance. I’ve petitioned FDA in an attempt to prevent reclassification of devices to higher risk Class medical devices. Additionally, I’ve built and improved processes necessary to introduce new products to various global markets. As a leader and a mentor, I’ve coached and developed junior level RA/QA professionals, I’ve utilized excellent written and verbal communication skills, employed project management skills, exercised lean/six sigma process improvement skills and have been a leader in driving to achieve various regulatory and quality goals; both in pre-market and post market regulatory environments.

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