Yogesh Murali
Regulatory Affairs & Quality Assurance | TÜV SÜD Certified Lead Auditor I Strategizing Compliance with Emerging Global Regulations | HCL Technologies
- Role
- Senior Analyst at HCLTech
- Location
- Chengalpattu, TN, IN
- LinkedIn followers
- 500 followers
About Yogesh Murali
As a Regulatory Analyst with over 3 years of experience in regulatory compliance, I specialize in ensuring medical devices and in vitro diagnostic devices (IVDs) meet global standards and regulations. My expertise lies in regulatory strategy, standard assessments, and compliance documentation, enabling businesses to confidently navigate complex regulatory landscapes.Key Highlights- Proficient in identifying country-specific applicable standards for POC IVD and medical devices- Performed GAP assessments for labeling, packaging, usability, and risk management standards- Spearheaded compliance activities for Battery Regulation 2023/1542 and the Radio Equipment Directive (RED) 2014/53, ensuring regulatory readiness- Successfully prepared compliance documentation for RED and facilitated uploads in SAP P41- Ensured labeling compliance with IATA 2024 Lithium Battery Regulations across multiple product lines- Conducted material regulation assessments, including REACH, RoHS, and Proposition 65 compliance- Supported new product development (NPD) by mapping standard applicability, deriving requirements, and identifying test cases for innovative products.
Experience
Senior Analyst
Dec 2024 — Present · Chennai, IN
Education
Rajalakshmi Engineering College
Bachelor of Engineering - BE
2017 — 2021
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