Regulatory Associate

Medical device manufacturer located in Rockland County, NY, is seeking a Regulatory Associate to be responsible for the following job duties:

 

-Interact with FDA, Notified Body, authorized European representative or any other third-party agency, at direction of Director, QA/RA

-Perform  audits of internal procedures

-Ensure QSR, MDD, CMDR and ISO compliance.

-International product registrations.

-Write and submit 510(K)s to FDA; provide follow-up

-Assist Director, QA/RA in determining regulatory path for new products or product modifications

-Prepare & obtain approvals for letters to file

-Perform timely review of complaints for reportability (US, EU, Canada)

 

Ideal candidates will possess: 



-Strong regulatory affairs background (RAC a plus)

-Strong communication ability both verbal and written. 

-At least two years of medical RA, class I sterile disposable & class II durable products experience preferred