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.
2. 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.
- 3. 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.
Coordinate and participate in regulatory audits and inspections.
Address findings and implement corrective and preventive actions (CAPA) as needed.
Access and manage product risks in accordance with applicable standards.
Develop and maintain risk management files and reports.
- 6. 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.
- 7. 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)
Job Type: Full-time
Education:
Experience:
- total work: 5 years (Preferred)
Work Location: In person
