Zoheb Мuhammad

About Zoheb Мuhammad

Global Regulatory Affairs, Quality Assurance, and Clinical Research leader with 14 years of experience across India, South Asia, Southeast Asia, the United States, and the European Union within the medical devices, diagnostics, digital therapeutics, and Software as a Medical Device (SaMD) landscape.Currently leading global Regulatory Affairs, Quality Assurance, and Clinical Operations at Dr. Reddy’s Laboratories, with end-to-end ownership of regulatory strategy, global submissions and approvals, QMS governance, audits, clinical operations, and post-market activities. Deep expertise across ISO 13485, FDA 21 CFR Part 820, EU MDR, ISO 14971, IEC 62304, and CDSCO requirements.Recognized for building scalable quality systems, leading global audits, driving regulatory intelligence, supporting innovative therapies, and enabling successful commercial launches across regulated markets. Strong track record of cross-functional leadership, distributor and supplier oversight, and lifecycle management for both hardware and software-based medical technologies.

Experience

1. Director - Medical Device Regulatory Affairs & Quality Assurance

   Dr. Reddy's Laboratories

   Jul 2022 — Present · Hyderabad, IN

   Head of Regulatory Affairs, Quality Assurance, and Clinical Operations for Medical Devices, IVDs, Digital Therapeutics, AI-based solutions, and SaMD portfolios-Established and governed QMS frameworks aligned with ISO 13485, FDA QSR, EU MDR, and regional regulations-Led global regulatory submissions, approvals, and commercial launches across India, US, EU, Middle East, South Africa, and CIS-Defined clinical and regulatory strategies for innovative therapies across oncology, neurology, and rare diseases-Built a global regulatory intelligence playbook to guide strategic registration pathways for emerging technologies-Directed compliance audits, risk management, post-market surveillance, design changes, and lifecycle management-Led and mentored cross-functional, geographically distributed teams across RA, QA, and Clinical functions

Education

• Swiss School of Management

  Doctor's Degree, Business Administration and Management, General

Skills

• Oracle Clinical
• Fermentation
• Sds-Page
• Spectrophotometry
• Pcr
• Bioinformatics
• Chromatography
• Hplc
• Elisa
• Microbiology
• Biotechnology
• Clinical Research
• Clinical Data Management
• Pharmacovigilance
• Medical Writing
• Clinical Trial Management
• Iso 13485
• Quality System
• Fda
• Pharmaceutical Industry
• U.s. Food and Drug Administration (Fda)
• Clinical Trials
• Ctms
• Quality Assurance
• Medical Devices
• Good Clinical Practice (Gcp)
• Corrective and Preventive Action (Capa)
• Standard Operating Procedure (Sop)
• Electronic Data Capture (Edc)
• U.s. Title 21 Cfr Part 11 Regulation
• Regulatory Requirements
• Change Control