Quality Assurance Regulatory Affairs Manager

3 - 7 years

0 Lacs

Posted:2 weeks ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a Quality Cum Regulatory Assurance Executive at Elesonic Healthcare Private Limited, your role will involve overseeing and implementing quality control and assurance processes, conducting quality audits, and managing quality systems. You will work closely with various departments to ensure compliance with regulatory standards and maintain high-quality manufacturing standards for medical equipment. **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 (i.e., AERB, BIS, CDSCO, ISO 13485 European, 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 have the ability to pass - Prior experience in the medical equipment industry is a plus Join Elesonic Group in their mission to make the world a healthier place by ensuring quality and exceptional service in the industry. As a Quality Cum Regulatory Assurance Executive at Elesonic Healthcare Private Limited, your role will involve overseeing and implementing quality control and assurance processes, conducting quality audits, and managing quality systems. You will work closely with various departments to ensure compliance with regulatory standards and maintain high-quality manufacturing standards for medical equipment. **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 (i.e., AERB, BIS, CDSCO, ISO 13485 European, 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 have the ability to pass - Prior experience in the medical equipment industry is a plus Join Elesonic Group in their mission to make the world a healthier place by ensuring quality and exceptional service in the industry.

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