Regulatory Affairs Senior Specialist - Irvine

This position is for a Regulatory Affairs Senior Specialist. If you are interested in preparing submissions for innovative, life-saving devices, then this opportunity is for you. I am looking for candidates who have played major roles in preparing 510(K) clearances. If you have experience working on submissions for software-driven and electronic devices, you are also highly valued. Preferrably, you will have at least three years of experience in regulatory affairs in the medical device industry. A good candidate will have a bachelors--or even better--a masters degree. The team's culture is one of high ambition, energy, and dedication.

As senior specialist, you will prepare and write 510(K) clearances to the FDA and other global agencies. You will work to represent the regulatory affairs team in inter-departmental matters. You will mentor less-experienced regulatory affairs specialists and report to the manager and director, providing leadership and advice to all. You will help grow the team and establish its practices for successful device clearances and communication with the FDA.

If this sounds like a good fit, then I look forward to hearing from you!
To find out more about Real please visit www.realstaffing.com