Quality Assurance Regulatory Affairs Manager

As a Quality Cum Regulatory Assurance Executive at Elesonic Healthcare Private Limited located in Kolkata, your role involves overseeing and implementing quality control and assurance processes for medical equipment manufacturing. You will be responsible for conducting quality audits, managing quality systems, and ensuring compliance with regulatory standards. Your collaboration with various departments such as AERB, BIS, CDSCO, and European Agency for ISO and CE will be essential in maintaining high-quality manufacturing standards. **Key Responsibilities:** - Implementing and achieving Quality Control, Quality Assurance, and Quality Management skills - Experience in Quality Control and Quality Assurance processes - Proficiency in Quality Management systems and practices - Knowledge of Medical Device Regulations including AERB, BIS, CDSCO, ISO 13485 European, and CE European - Strong analytical and problem-solving skills - Excellent attention to detail and organizational abilities - Ability to work effectively in a team and independently **Qualifications:** - Bachelor's degree in a related field (e.g., Life Sciences, Engineering, or Quality Management) - Must have Physics as one of the subjects in Bachelor's Degree - Radiological Safety Officer (RSO) Exam from AERB passed is preferred, and if not passed, then the ability to pass is required - Prior experience in the medical equipment industry is a plus,