Tejas Aware

Sr Regulatory Affairs Executive at Maven Profcon Services Llp

Based in Nashik, India

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Seniority

Manager

Department

General Business & Management

Location

Nashik

Industry

Business Consulting and Services

Company size

74

Contact information

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Email

1 credit

t•••••••@mavenprofserv.com

Phone

5 credits

+91 ••• •••• ••••

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Background

About Tejas Aware

Regulatory Affairs Executive with 2+ years of experience in EU MDR 2017/745 compliance across Class medical devices including SaMDs, implants, disposables, and active devices. Contributed to 20+ technical documentation files for CE marking and regulatory approvals. Familiar with FDA regulations and 510(k) pathways for U.S. market entry. Successfully mentored 20+ interns, nurturing future regulatory talent. Skilled in cross-functional collaboration with QA, R&D, clinical, and marketing teams. Recognized with 'Best Squad' and 'Multitasker Pro' awards. Passionate about advancing regulatory frameworks for SaMD and active medical devices.

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