Regulatory Affairs for Medical Devices plays a crucial role in ensuring that medical products comply with all necessary regulations and standards before they can be marketed and used in different countries. This discipline involves the preparation, submission, and maintenance of documentation required by health authorities, such as CE marking in Europe, FDA approval in the USA, and other international certifications. Professionals working in this area help manufacturers navigate complex regulatory frameworks, stay updated with constantly evolving guidelines, and manage product registrations efficiently. Their work ensures the safety, quality, and effectiveness of medical devices while enabling timely access to global markets. Regulatory Affairs experts also handle post-market surveillance, product recalls, and regulatory strategy development, acting as a bridge between manufacturers and health authorities to maintain ongoing compliance.