HCL Technologies is a next-generation global technology company that helps enterprises reimagine their businesses for the digital age. Our technology products and services are built on four decades of innovation, with a world-renowned management philosophy, a strong culture of invention and risk-taking, and a relentless focus on customer relationships. HCL also takes pride in its many diversity, social responsibility, sustainability, and education initiatives. Through its worldwide network of R&D facilities and co-innovation labs, global delivery capabilities, and over 197,000+ Ideapreneurs across 52 countries, HCL delivers holistic services across industry verticals to leading enterprises, including 250 of the Fortune 500 and 650 of the Global 2000. HCL is Hiring for Regulatory Affair for one of the leading product based client. Come join us in reshaping the future Qualification Required: BE/B.Tech/M. Tech/MCA educational background. Exp required : 12 to 20 yrs. Job Location: Chennai Notice Period: max 60 Days Key Skill: Skill set: Extensive Experience in ISO 13485, ISO 9001, FDA QSR (21-CFR-820), EU-MDR, India-MDR Experience in ISO 14971, IEC 62304 Experience in handling QMS for High Risk Programmable Electro-Mechanical Medical Devices (US-FDA Class-3 or India MDR-Class-D) (experience with Implantable device is nice to have) Use of excel sheet or other statistical tools for Data analysis If you are interested in exploring this job profile, please share your updated profile to [HIDDEN TEXT] for detailed discussion. How You Wll Grow At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best. Why Us We are one of the fastest-growing large tech companies in the world, with offices in 60+ countries across the globe and 222,000 employees Our company is extremely diverse with 165 nationalities represented We offer the opportunity to work with colleagues across the globe We offer a virtual-first work environment, promoting a good work-life integration and real flexibility We are invested in your growth, offering learning and career development opportunities at every level to help you find your own unique spark We offer comprehensive benefits for all employees We are a certified great place to work and a top employer in 17 countries, offering a positive work environment that values employee recognition and respect
