Asarudeen N

Regulatory Affairs and Compliance professional with experience supporting Class II medical devices, US FDA 510(k), FDA eSTAR, CDSCO registrations, and ISO 13485 Quality Management Systems. Skilled in regulatory submissions, technical documentation, Design Controls, ISO 14971 Risk Management, Clinical Evaluation Reports (CER), Verification & Validation, and cross-functional collaboration. Additional experience in enterprise compliance, internal audits, CAPA, ISO 27001, ISO 27701, ISO 22301, and ISO 9001.

Member Technical Staff Compliance - Zoho Corporation - Chennai, India

(2025-12)

• Support enterprise GRC programs across ISO 27001 (ISMS), ISO 27701 (PIMS), ISO 9001 (QMS), and ISO 22301 (BCMS) to maintain certification and regulatory compliance.
• Conduct internal audits, validate control effectiveness, track CAPA implementation, and support continual improvement initiatives.
• Maintain compliance documentation, policies, SOPs, audit evidence, and records for internal, external, and customer assurance audits.
• Review privacy controls and product documentation against GDPR, HIPAA, and ISO 27701 requirements while collaborating with engineering, legal, and product teams.
• Key Achievement: Supported successful ISO 27001, ISO 27701, ISO 22301, ISO 9001, SOC 1, SOC 2, CSA STAR, HIPAA, DESC, and SS 584 certification audits.

Regulatory Affairs - MaGa Tech Gramam Pvt. Ltd. - Karaikudi, India

(2024-07 - 2025-12)

• Led regulatory activities for Class II medical devices targeting US FDA and CDSCO markets in collaboration with R&D, Quality, Manufacturing, and Clinical teams.
• Prepared FDA 510(k), FDA eSTAR, Pre-Submission, and CDSCO regulatory submission packages, including technical documentation, labeling, and supporting evidence.
• Prepared DHF, Design Control documentation, ISO 14971 Risk Management Files, Clinical Evaluation Reports (CER), and Verification & Validation documentation supporting regulatory submissions.
• Coordinated EMI/EMC, Electrical Safety, ISO 10993 Biocompatibility, Aging Studies, and Verification & Validation testing through accredited laboratories.
• Key Achievement: Completed two FDA 510(k) submissions and Pre-Submissions, prepared CDSCO Manufacturing and Test License documentation, and led ISO 13485 QMS implementation.

Engineer Trainee - MaGa Tech Gramam Pvt. Ltd. - Karaikudi, India

(2023-11 - 2024-07)

• Supported medical device design, prototyping, verification testing, and product validation with R&D, Manufacturing, and Quality teams.
• Performed device assembly, sensor fabrication, data analysis, and performance testing to support product development.
• Prepared technical documentation, engineering records, and verification reports supporting regulatory and quality requirements.

B.E. - Mechanical Engineering - Alagappa Chettiar Government College of Engineering & Technology (2020 - 2024) Karaikudi