RAO Regulatory Affairs And Validation Officer Job

Key responsibilities:

1. Prepare, review, and execute user requirements specifications (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
2. Conduct thorough process validations for manufacturing equipment and procedures specific to the production of single-use medical devices and dialysis consumables.
3. Validate clean room environments and HVAC systems in accordance with regulatory standards and ensure consistent environmental control.
4. Develop, manage, and maintain documentation required for audits, including those related to ISO 13485, GMP compliance, and other regulatory standards.
5. Ensure compliance with international medical device standards, including ISO 13485 and good manufacturing practices (GMP) for medical device production.
6. Assist in the preparation of regulatory submissions and ensure ongoing compliance with local and international regulatory frameworks.
7. Participate actively in both internal and external audits and ensure that all validation and regulatory documentation is ready for audit purposes.
8. Collaborate with cross-functional teams to implement validation protocols and regulatory strategies.

1