Verified recordBiotechnology Research

Barathkumar Manoharan

Regulatory Affairs Specialist at Cepheid

Based in Toronto, Canada

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Seniority

Staff

Department

Science

Location

Toronto

Industry

Biotechnology Research

Company size

4.7K

Contact information

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Email

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b•••••••@cepheid.com

Phone

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Background

About Barathkumar Manoharan

As a Regulatory Affairs and Quality Assurance Associate, I bring 4 years of experience in the MedTech industry, specializing in navigating regulatory landscapes and ensuring compliance with international standards. My expertise spans across EU MDR, US FDA, Health Canada MDR, ISO 13485, and ISO 14971, making me proficient in regulatory compliance transitions, QMS development, regulatory writing, and submissions. My technical skills in root cause analysis, SOP development, project management, and data analysis are complemented by my proficiency with tools like PLM Windchill, Arbortext Editor, Adobe Creative Cloud, MS Office Suite, Google Suite, and eQMS platforms. Holding a Master’s degree in Regulatory Affairs from Northeastern University and certifications as an ISO 13485 Lead Auditor, RAPS RCC MDR and Lean Six Sigma professional, I am committed to maintaining high standards of regulatory compliance and quality management.

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