Gurunathan M Email & Phone Number

Madurai, Tn, In

Madurai, Tamil Nadu, India

As a Regulatory Affairs Executive with [2year & 7 month] years of experience in the medical device industry, I specialize in navigating the complex regulatory landscape to ensure compliance and successful product approvals. My role involves: Crafting and implementing regulatory strategies that align with business goals and comply with international regulations and standards.Documentation and Submission: Preparing, reviewing, and submitting regulatory documents to health authorities (e.g., FDA, Eu-MDR, IMDR) for new product approvals, renewals, and amendments.Compliance Monitoring: Ensuring ongoing compliance with regulatory requirements by monitoring changes in legislation and guidelines and updating internal processes accordingly.Cross-functional Collaboration: Working closely with R&D, Quality Assurance, Manufacturing, and Marketing teams to ensure regulatory requirements are met throughout the product lifecycle. Risk Management: Identifying potential regulatory risks and developing mitigation strategies to avoid delays or non-compliance issues.Regulatory Audits: Leading and supporting internal and external regulatory audits and inspections.My dedication to regulatory excellence has enabled me to contribute to the successful launch and maintenance of various products in the market, ensuring patient safety and adherence to regulatory standards.