Regulatory Affairs Specialist

Role: Regulatory Affairs Manager for medical device products. Responsibilities Include Managing submissions, registrations, and listings for medical devices.Conducting complaint investigations, product reviews, and post-market surveillance.Performing audits and reviewing technical files to ensure compliance.Supporting staff training on regulatory requirements.Coordinating with regulatory agencies and advising stakeholders on compliance risks.Ensuring adherence to domestic and international regulations and quality system standards. Qualifications & Skills Knowledge of medical device regulations and quality systems.Strong understanding of regulatory submission processes and compliance management.Excellent communication and coordination abilities.Attention to detail in audits, reviews, and investigations.