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3 days ago
Job Title: Quality Assurance and Regulatory Associate
">- Ensuring product quality and conformity to regulatory standards is a key responsibility.
Key Responsibilities:
">- Conduct internal audits, review management review meeting minutes, and investigate complaints.
- Update quality manuals, SOPs, and formats according to ISO 13485:2016 guidelines.
- Prepare technical files, including instructions for use, labeling, packaging information, and patient information leaflets as per EU MDR 2017/745.
- Review certificates of analysis, sterilization check sheets, calibration reports, and other relevant documents.
- Oversee microbiology and quality control activities, including water testing, media preparation, and instrument operation.
- Maintain site master files and device master files in compliance with Indian MDR.
- Deliver training sessions on quality-related topics.
- Stay updated on regulatory changes, including EU MDR requirements.
- Assist in preparing clinical evaluation reports, risk management analyses, and other regulatory documents.
Required Skills and Qualifications:
">- Documentation Executive
- Quality Assurance Specialist
- Regulatory Affairs Expert
Benefits:
">A challenging role that requires expertise in quality assurance and regulatory affairs. The ideal candidate should have excellent communication skills and the ability to work independently.
">Others:
">The selected candidate will receive comprehensive training and support to ensure their success in this role.
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