Riazur Rahman

About Riazur Rahman

As a Senior Regulatory Affairs Manager in the medical device industry, I specialize in global regulatory strategy, compliance, and market access, ensuring products meet FDA (510(k), PMA, De Novo), EU MDR/IVDR, and other international requirements. I have successfully led regulatory submissions, product lifecycle management, and post-market surveillance while collaborating cross-functionally with R&D, Quality, and Clinical teams. My expertise includes ISO 13485, QSR, MDSAP, and risk management, enabling me to navigate complex regulations and streamline approval processes. Passionate about patient safety and regulatory excellence, I stay ahead of evolving regulations to drive innovation and business success. Let’s connect to discuss regulatory strategies and best practices in the medical device industry!

Experience

1. Senior Regulatory Affairs Manager

   Healgen Scientific

   Sep 2024 — Present · Houston, TX, US

   Develop and manage global regulatory databases, tools, and strategies for high-complexity medical devices, including IVDs, SaMDs, CDx, and SiMDs, achieving high approval rates across multiple regions (e.g, 510(k), PMA, CE Mark, TGA, Health Canada)- Manage and mentor regulatory teams in the US, Canada, and China, fostering collaboration and ensuring compliance with global standards and post-market requirements-Direct regulatory filings, post-market surveillance, recalls, and risk management, ensuring adherence to ISO 13485, ISO 14971, MDR, and IVDR regulations- Collaborate with R&D and QA teams to enhance product design, usability, and compliance, while serving as the primary liaison with regulatory authorities and notified bodies- Oversee audits, compliance testing, labeling approvals, and import/export certifications to support global market access for medical and veterinary devices- Lead and mentor regulatory teams across the US, Canada, and China, overseeing submissions, compliance, and post-market activities (e.g, recalls, MDR, and vigilance)- Serve as the primary regulatory contact with authorities, directed audits (FDA, MDSAP, IVDR), and managed product compliance testing and labeling approvals- Support veterinary IVDs, dietary supplements, and regulatory education initiatives, ensuring alignment with global market requirements.

Education

• Texas State University

  Master of Science - MS, Engineering/Industrial Management

  2015 — 2016