Role can be based at either our Irvine, CA or Pleasanton, CA campus)
The Sr. Manager Regulatory Affairs represents US Regulatory Affairs for Body Contouring development projects and marketed medical devices. Working with manager, responsible for development and communication of global regulatory strategy on R&D project teams.
Ensures technical accuracy and regulatory compliance of all submissions for which they are responsible and ensures that applications are executed appropriately and submitted on time. Has authority to make decisions on US regulatory strategy and to submit complex submissions.
Directs communications and interactions with US FDA and other regulatory agencies as needed. Acts as primary contact for the US FDA and supports interactions with our Notified Body. Supports management with development of, and as appropriate, leads implementation of department
strategies and policies.
Applicable to California Applicants Only
The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California. This range may be modified in the future.
The salary range for this role is posted below
This job is eligible to participate in our short-term incentive program
This job is eligible to participate in our long-term incentive programs
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
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