Description
This position is for Regulatory Affairs Senior Specialist. If you are interested in joining a world-reknown company and have the unique desire to work on an original PMA submission, then this opportunity is for you. I am looking for candidates who have played major roles in preparing 510(K) clearances. Experience working on PMA supplements or an original PMA is highly valued as well. You should have a minimum of three years of regulatory affairs experience in the medical device industry and a bachelors degree. The team's culture is one of high energy, ambition, and dedication.As senior specialist, you will prepare and write 510(K) clearances, as well as work on an original PMA submission and subsequence PMA supplements. You will work to represent the regulatory affairs team in inter-departmental matters and you will communicate regularly with global submission agencies, particularly the FDA. 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 future device clearances and communication with the FDA.
If these descriptions apply to you, I look forward to hearing from you.
To find out more about Real please visit www.realstaffing.com