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Vice President, Regulatory Affairs & Quality Assurance
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- The Vice President, Regulatory Affairs and Quality Assurance implements regulatory strategies worldwide to 1) ensure that regulatory requirements are met, and 2) obtain regulatory approval for Pulmonx products.
- Define and lead the Regulatory and Quality strategies for the company, including Regulatory submissions, product development and registration activities, post-market surveillance, Quality Management Systems, audits.
- Act as a liaison to the FDA and ensure timely responses to regulatory agency inquiries.
- Direct and oversee the Pulmonx Customer Experience Reporting (i.e. Complaint Handling) system, including product investigations and evaluation of each reported event for regulatory reporting pursuant to - but not limited to - the Medical Device Reporting, Vigilance Reporting and Mandatory Reporting regulations of the U.S., European Union, Canada and emerging market countries.
- Lead all ancillary regulatory functions (e.g. promotional material review, labeling, etc.)
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