Seenivasan Sriee Selvaraj
Regulatory Affairs Specialist Ii Data Governance & Operations @美敦力
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WORK HISTORY
Regulatory Affairs Specialist Ii Data Governance & Operations @美敦力
Hyderabad, IN
Driving regulatory operations across the full medical device lifecycle — with a specialized focus on Global Regulatory Data Governance, UDI Database Management, and Regulatory Information Management across the CST (Cranial & Spinal Technology) and Enabling Technologies portfolio. & Leading the development and maintenance of a centralized global regulatory database — feeding accurate, compliant data into country-specific regulatory authority systems across FDA (USA), TGA (Australia), HSA (Singapore), MDA (Malaysia), and EUDAMED (EU). & Collecting, validating, and enriching critical product data attributes from various regulatory and product data sources — ensuring accurate and compliant submissions per each country\'s specific regulatory requirements.() Managing enterprise-level regulatory information and submission lifecycle using Calyx and RedDesk— ensuring structured, compliant, and audit-ready regulatory records across global product portfolios. & Supporting end-to-end product registration and market release across global markets — ensuring every device meets local regulatory requirements before reaching patients. & Driving continuous process improvement across regulatory operations while actively contributing to capability building through regulatory training programs and knowledge sharing initiatives.
EDUCATION
SMK FOMRA INSTITUTE OF TECHNOLOGY
Bachelor of Engineering (B.E.), Biomedical Engineering
ABOUT SEENIVASAN SRIEE SELVARAJ
From vascular intervention to cranial & spine systems — 8+ years. Seven device categories. One constant: getting safe, compliant medical devices to the patients who need them.I am a Biomedical Engineer and Regulatory Affairs Specialist with hands-on experience across the full medical device lifecycle — from concept to commercialization. 🫀 Endovascular & Peripheral Intervention — IV Filters, Biopsy Systems & Vascular Access 🦷 Dental Implant Systems — Class II & 🦴 Orthopaedic Reconstruction — Knee, Hip & Joint Systems 🧬 Collagen-Based Biological Implants — Animal Origin Class Cardiovascular Life Support — Heart-Lung Machine & Perfusion Components Surgical Instrument Portfolio — General & Speciality Surgical Systems 🧠 Cranial & Spine Enabling Technologies — Neurosurgical & Spinal Systems Regulatory Data Governance FDA 510(k) & CE Marking Submissions EU MDR (2017/745) & 21 CFR Part 820 & 803 DHF Remediation & Design Control DMF, STED & GSPR Documentation PMS, PMSR & PSUR Reporting Complaint Handling & Vigilance Reporting Supplier Quality & Risk Management Process Optimization & Continuous Improvement 8+ Years · 7 Device Categories · Class II & · FDA | EU MDR | ISO 13485Patient safety drives everything I do.Beyond regulatory work, I actively contribute to mental health support, environmental conservation, wildlife protection, and social inclusion — because impact, for me, extends well beyond the workplace.Open to connecting with regulatory professionals, industry leaders, and organizations making a difference in medical device compliance.
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