Sr. Manager, Regulatory Affairs

Outset Medical is seeking a Sr. Manager, Regulatory Affairs to provide strategic leadership and oversight in all regulatory aspects related to our medical device portfolio. The ideal candidate will have a minimum of 8 years of regulatory affairs experience in the medical device industry and in-depth knowledge of medical device regulations and standards.

Requirements

• Develop and execute regulatory strategies for the successful development, registration, and commercialization of medical devices in the US.
• Provide regulatory guidance and expertise to cross-functional teams, including R&D, Quality Assurance, Clinical Affairs, and Marketing.
• Assess and interpret regulatory requirements and provide recommendations on product development plans, labeling, human factor study, and clinical trial designs to ensure compliance.
• Manage and review regulatory submissions, including 510(k) premarket notifications, 510(k), De-Novo applications, Pre-submissions, and IDEs.
• Stay current with evolving regulatory requirements, industry trends, and best practices, and proactively communicate updates and potential impacts to stakeholders.

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan