Rohan Singh

About Rohan Singh

Compliance is not just a requirement; it is the foundation for safe and effective medical products\"I am a Regulatory Affairs Associate with around 2 years of experience in the medical device and pharmaceutical sectors, specializing in regulatory compliance, dossier preparation, and lifecycle management. My work focuses on ensuring that medical products meet global regulatory standards while maintaining operational precision and quality. I have hands-on experience in STED documentation, SUGAM portal submissions, ISO 13485 implementation, and EU MDR & IMDR compliance, enabling me to navigate complex regulatory processes effectively.Previously, at Medtronic, I managed regulatory operations for a wide medical device portfolio, preparing technical dossiers, monitoring regulatory intelligence, maintaining trackers for 178 licensed products, handling SAE reporting for CRM and CRDN portfolios, and supporting post-approval MD-14 submissions for the spine portfolio.Throughout my professional journey, I gained expertise in regulatory affairs for medical devices and pharmaceuticals, including PSUR, post-market surveillance, and QMS standards across multiple regions. At Sandoz Development Centre, I evaluated project feasibility, validated nanosuspension formulations, supported NCE filings, and assisted in CTD quality documentation following ICH guidelines.Significant Key Achievements Maintained accurate regulatory records for 178 licensed products, ensuring accessibility and compliance Successfully managed SAE reporting for CRM and CRDN portfolios Prepared comprehensive dossiers and technical files for EU MDR & IMDR compliance Supported post-approval changes and MD-14 submissions for spine portfolio Conducted feasibility assessments for three internal pharmaceutical development projects Validated nanosuspension formulations, enhancing project decision-makingCore SkillsRegulatory Compliance Dossier Submission Management STED Documentation SUGAM portal navigation EU MDR & IMDR Regulations Post-Approval Submissions Regulatory Intelligence SAE reporting Regulatory Compliance Dossier Management STED DocumentationSUGAM PortalEU MDR & IMDR Post-Approval SubmissionsI am committed to advancing regulatory compliance and ensuring medical products meet international standards. I welcome opportunities to connect with professionals and organizations in the medical device and pharmaceutical sectors to exchange insights and contribute to regulatory excellence.

Experience

1. Ra Trainee

   Medtronic

   Feb 2025 — Present · Gurugram, IN

   In my role as a trainee at Medtronic, I managed regulatory operations for a wide portfolio of medical devices, ensuring compliance with global standards and supporting post-approval submissions. I prepared technical dossiers, monitored regulatory intelligence, and maintained meticulous records for over 178 licensed products. Optimized GSR 102 submission processes by consolidating STED documents, enhancing medical device regulatory workflow efficiency. Generated and circulated regulatory intelligence reports, providing actionable insights on EU MDR, IMDR, and industry developments. Maintained comprehensive regulatory trackers, safeguarding document integrity and expediting submission timelines across multiple product portfolios. Managed SAE reporting for CRM and CRDN portfolios, overseeing documentation and submission throughout the entire reporting lifecycle. Supported post-approval changes and MD-14 submissions for the spine portfolio, ensuring compliance while balancing operational continuity.Regulatory Compliance, STED Documentation, SUGAM Portal, NPI Submissions, SAE Reporting

Education

• Manipal College of Pharmaceutical Sciences

  M Pharmacy , Pharmaceutics and Drug Design

• Punjab Technical University, Jalandhar

  Studying Bpharma

  2018 — 2022