Regulatory Compliance Specialist

7 days ago


Sunnyvale, California, United States Ihealth Labs Inc Full time
Key Responsibilities

The Regulatory Compliance Specialist will be responsible for ensuring compliance with FDA and ISO 13485 quality system regulations and requirements.

This includes internal and external quality audits, organizing/conducting internal audits and management reviews, hosting external audits, and following up on audit findings and management review actions.

The successful candidate will also be responsible for verifying and validating computer systems used in managing QMS-related activities and interacting with local regulatory authorities and auditing bodies.



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