Raghul G
Regulatory Affairs Specialist | Medical Devices & IVD | CDSCO | EU IVDR | CE Mark | US FDA | ISO 13485 | Risk Management | Clinical Evaluation | Global Regulatory Strategy
- Role
- Regulatory Affairs Executive at Morulaa Healthtech Pvt. Ltd
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Raghul G
As a dynamic Doctor of Pharmacy graduate, I am actively pursuing opportunities within esteemed health and research organizations. My goal is to apply my extensive knowledge, honed abilities, and interpersonal adeptness in a role that encourages innovation, adaptability, and resourcefulness. I am enthusiastic about contributing to an institution that fosters both my professional advancement and my passion for imparting knowledge through teaching and pioneering research endeavors, emphasizing exceptional academic communication.
Experience
Regulatory Affairs Executive
Feb 2025 — Present · Chennai, IN
Lead end-to-end regulatory strategy and compliance management for Medical Devices and IVD products across India, EU, and US markets.• Manage CDSCO registrations and CE Mark submissions for Class IIa, IIb, and Class medical devices.• Provide complete regulatory lifecycle support for USA-based clients, from product classification to post-market compliance.• Prepare and maintain Technical Files, Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), GSPR checklists, Risk Management Files (ISO 14971), and Declarations of Conformity.• Develop and review PMS Plans, PSUR, PMCF documentation, vigilance reports, and adverse event submissions.• Lead IVDR-aligned documentation upgrades to ensure EU compliance readiness.• Implement and support ISO 13485:2016 QMS activities including CAPA, internal audits, supplier qualification, and document control.• Conduct regulatory impact assessments and manage variation/supplement submissions.• Draft and defend responses to deficiency letters and audit observations from CDSCO and Notified Bodies.• Act as primary liaison with regulatory authorities, Notified Bodies, and international stakeholders.• Track global regulatory intelligence (EU MDR/IVDR, CDSCO, US FDA) to ensure proactive compliance alignment.Strengthening regulatory frameworks and accelerating global market access through strategic, evidence-based regulatory leadership.
Education
The Tamil nadu Dr.MGR medical University
Doctor of Pharmacy - PharmD, Pharmacy
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