QA & RA Associate

4 weeks ago

Ahmedabad Gandhinagar, India Mantras2success Consultants Full time

Job Description Key Responsibilities: - Ensure product quality and conformity to regulatory standards, including Medical Device Regulation (MDR) and Quality Management System (QMS). - Conduct internal quality audits and participate in management review meetings. - Handle investigations of complaints and implement corrective and preventive actions. - Maintain and update quality manuals, formats, and standard operating procedures (SOPs) in accordance with ISO 13485:2016. - Prepare technical files, including Instructions for Use (IFUs), labeling, packaging information, and patient information leaflets, as per EU MDR 2017/745. - Review certificates of analysis (COA), sterilization check sheets, calibration reports, and other relevant documents. - Oversee microbiology and quality control activities, including water testing, media preparation, and instrument operation. - Ensure compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and regulatory requirements. - Prepare and maintain site master files and device master files in compliance with Indian MDR. - Conduct training sessions on quality-related topics. - Stay updated on regulatory changes, including EU MDR requirements. - Assist in the preparation of clinical evaluation reports, risk management analyses, and other regulatory documents. - Review and update quality manuals, device master files, and other essential documents for compliance. Key Skills : - Documentation Executive - Qa - Regulatory Affair

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