Manager - Quality Assurance

As a Regulatory Affairs and Quality Assurance professional, you will be responsible for ensuring compliance with medical device regulations and quality standards. Your key responsibilities will include: - Stay updated on medical device regulations, standards, and guidelines such as FDA, ISO, and CE Marking to ensure product compliance. - Develop and implement quality assurance processes and procedures to maintain product quality. - Conduct internal audits and assessments to identify areas for improvement. - Collaborate with production teams to establish quality control measures. - Maintain and organize regulatory and quality documentation for filing and submissions. - Coordinate and participate in regulatory audits and inspections and implement corrective actions as required. - Manage product risks in alignment with applicable standards and maintain risk management files. - Collaborate with cross-functional teams including R&D, manufacturing, and clinical teams to ensure regulatory compliance. - Monitor and report adverse events or non-compliance issues for post-market surveillance. Qualifications required for this role include: - Bachelor's degree in Science, B.Pharma/M.Pharma, Biomedical Engineering, or Diploma in Regulatory Affairs or Quality Management System. - Minimum 6 years of experience in Quality Assurance and Regulatory Affairs. - Knowledge of medical device regulations and quality standards such as FDA 21 CFR Part 820 and ISO 13485. Additionally, the company values your expertise in regulatory compliance and quality assurance to ensure the successful development and maintenance of medical devices in adherence to regulatory requirements and quality standards.,