Join the National Placement Services team as a Full Time QARA on Erekrut, specializing in QARA in the Medical industry. We are seeking talented individuals with a passion for Pharmaceutical & Biopharmaceutical and educational qualifications ranging from 1-3 Years. Apply now on Erekrut to take the next step in your career with a leading global company.
CTC- 20k-30k
- 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)