Description
The Medical Device Regulatory Affairs Specialist provides customer support on regulatory issues and leads CE marking, FDA 510(k) submissions, worldwide product registrations, risk management, engineering change reviews, post-market surveillance, audits, and regulatory inspections. The role requires a bachelor's degree, at least four years of regulatory experience, extensive knowledge of medical-device regulations and standards, and proficiency with Microsoft Office. The employer offers a hybrid or remote work model, 13th-month pay, a cafeteria package, and company equipment.
