Quality Assurance Regulatory Affairs

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)