Our Clinical-Regulatory team includes key members of Intuitive Surgical’s product teams who are responsible for regulatory submissions, complaint handling, internal/external auditing, clinical trial management and ensuring documentation is complete and consistent. Staff also maintain regulatory filings and licenses and work closely with regulatory agencies. This team provides leadership to our Development, New Product Introduction and Manufacturing teams for assessing the impact of design inputs and outputs on regulatory filings and compliance with quality systems. Additionally, they create awareness within the organization about international and domestic regulations and product-specific standards within the medical device field.
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The following teams make up our Clinical/Regulatory department:
- Regulatory Affairs
- Clinical Affairs
- Clinical Research
- Document Control