Compliances with regulatory requirements across various markets and increasing demands.
From increasing regulatory scrutiny to the integration and digital technologies in the medical devices industry.
Regulatory strategy from new product development, EU MDR transition, sustenance & Accelerating platforms by Cyient
Experienced senior manager with extensive regulatory affairs and quality assurance expertise in medical devices and in-vitro diagnostics, specializing in European regulations, audits, design control, regulatory authority liaison, recalls, vigilance reporting, and labeling.
Site Quality Leader and Sr. Engineering Manager with 18+ years of experience in Quality functions across R&D, manufacturing, distribution, post-market compliance, and Regulatory operations. He also has experience working in UK for a decade with Illumina Cambridge, J&J, Baxter, and AMRC-Boeing in various functional roles.
Experienced Manager with expertise in Product Lifecycle Management, Compliance & Regulatory, MEA, Sheet Metal, Lean Manufacturing, and PDM, holding a Bachelor of Engineering (BE) in Mechanical Engineering from the University of Madras
Experienced SME in medical device regulatory and quality assurance services, with achieved success in EU MDR-2017/745 sustenance program, creating CERS for Class I, II, and III medical devices, and implementing regulatory plans for NPD for 90+ countries.
Results-driven leader with 20+ years of experience in In-Vitro Diagnostics Market Research and consumer Packaged Goods, leveraging Six Sigma practices, change management, and talent development to drive client satisfaction, growth, quality & cycle time reduction.
Experienced global leader responsible for managing and leading a diverse team of business professionals accountable for sales & account management, business development, industry partnerships, engineering, manufacturing, and digital transformation services
Solution Architect working for Healthcare and Life sciences having 18+ years of R&D experience with Medical Device and Life Science companies. Mainly worked as Requirement Architect, Verification and Validation Manager, Risk Moderator, and Usability Engineer.
