Gowtham Ramkumar

Senior Associate Qa at Elexes Medical Consulting Llc

Based in Bengaluru, India

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Seniority

Staff

Department

Information Technology

Location

Bengaluru

Industry

Business Consulting and Services

Company size

40

Contact information

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Email

1 credit

g•••••••@elexes.com

Phone

5 credits

+91 ••• •••• ••••

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Background

About Gowtham Ramkumar

This is R.Gowtham and I am highly accomplished and focused on Quality Assurance and Regulatory Affairs in medical devices, specializing in the EU regulations. I possess excellent leadership, negotiation, oral/written communication, interpersonal, and analytical skills, and thrive in both independent and collaborative work environments. I was experienced in analyzing and reviewing various regulatory documents such as QMS documents, DHR, Risk management files, Usability engineering files, Clinical evaluation reports, labels, and instructions for use. Medical Device Quality Assurance and Regulatory Affairs || ISO 13485 || MDD / EU MDR 2017/745 || Risk Management || CAPA || Complaints Technical Investigation ||

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