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Regulatory Affairs Specialist

2 months ago

Irvine, United States Elevate Search Full time

Elevate Search is partnering with an Irvine-based medical device company developing an implantable breakthrough device for the US population to find a Regulatory Affairs Project Manager. This person will report to the Director of Regulatory Affairs.


This is an extremely exciting opportunity to assist with the FDA approval of a groundbreaking device (patients don't have another option in the US). In this role you will engage in monthly meetings with the FDA, have exposure to clinical trials, work closely with the leadership team, and be heavily involved in the PMA application process.


Required:

-Willingness to work onsite in Irvine at least 3 days a week.

-Bachelor's degree in scientific discipline

-Prior US experience

-PMA experience

-5+ years experience in Regulatory Affairs


The company offers exceptional benefits including medical, dental, and vision insurance, 401K match, annual bonus, PTO, 13 paid holidays, and more. The leadership team is extremely transparent and visible


Please email me your resume to learn more mmarsh@elevatesearch.com