My name is Engr. Ata Rasool, I am an experienced and qualified Executive Officer of Regulatory Affairs for Medical Devices with a proven track record of success in the medical device industry. I have a deep understanding of the regulatory landscape and a passion for helping companies bring innovative medical devices to market.I have been working in the medical device industry for over 05 years, and I have held a variety of positions in regulatory affairs, quality assurance, and manufacturing. In my previous role as Production Manager at Surgicrafts (Pvt) Ltd., I was responsible for maintaining the company's Quality Management System (QMS) to comply with EN ISO 13485:2016 + A11-2021, MDD 93/42/EEC as updated by 2007/47/EC, and FDA 21 CFR Part 820. I also ensured quality in production as per defined quality standards, maintained and improved procedures, work instructions, and quality system, handled customer complaints, conducted internal quality audits, and managed the manufacturing processes.In my current role as Executive Officer of Regulatory Affairs at QMS Certification International, I support company operations by acting as the general regulatory resource for the company. I research and render advice/opinions on regulatory matters, including regulatory evaluation of proposed changes to the facilities. I also provide services as a trainer, reviewer, compiler of Technical Documentation of EU/UK legislative requirements, and technical support for national as well as international clients on all kinds of technical matters of medical devices for EU/UK legislative compliance (EU MDR 2017/745).I am a highly motivated and results-oriented individual with a strong work ethic. I am also a team player and I am always willing to go the extra mile to help my team succeed. I am confident that I can make a significant contribution to your company and I look forward to hearing from you.Skillso Regulatory Affairso Quality Management Systemso Medical Deviceso CE Markingo FDA Complianceo ISO 13485o MDR 2017/745o MDD 93/42/EECo FDA 21 CFR Part 820o Technical Documentationo Stability & Shelf-life Studyo General Safety and Performanceo Registration with Competent Authoritieso ISO, ASTM, IEC, ENo Sterile / non-sterile / disposable / reusable Surgical & Dental Instrumentso Electrosurgical Instrumentso Surgical Accessories