Quality Assurance Regulatory Affairs
10 hours ago
Job Description:
Description :
Regulatory Compliance:
Stay updated on medical device regulations, standards, and guidelines (e.g., FDA, ISO, CE Marking).
Ensure that products meet all regulatory requirements and maintain relevant documentation.
Quality Assurance:
Develop and implement quality assurance processes and procedures.
Conduct internal audits and assessments to identify areas for improvement.
Collaborate with production teams to establish quality control measures.
Documentation Management:
Maintain and organize regulatory and quality documentation.
Prepare and submit regulatory filings, such as 510(k) submissions or CE Mark applications.
Create and update technical files and product documentation.
Compliance Audits:
Coordinate and participate in regulatory audits and inspections.
Address findings and implement corrective and preventive actions (CAPA) as needed.
Risk Management:
Access and manage product risks in accordance with applicable standards.
Develop and maintain risk management files and reports.
Cross-Functional Collaboration:
Collaborate with R&D, manufacturing, and clinical teams to ensure alignment with quality and regulatory requirements.
Provide regulatory guidance during product development and changes.
Post-Market Surveillance:
Monitor and report adverse events or non-compliance issues.
Educational Qualifications & Experience:
- Bachelor's degree in a Science or B.Pharma/M.Pharma or Biomedical Engineering or Diploma in Regulator Affairs, Quality Management System.
- 3-5 years of experience in Quality Assurance and Regulatory Affairs.
- Knowledge of medical device regulations and quality standards (e.g.- FDA 21 CFR Part 820, ISO 13485)
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