Description
My Client, a Medical Device company in New Jersey, is looking to bring on a Regulatory Affairs project manager.The position is a temp to perm position. You will start on a 6 month contract before the position becomes permanent.
responsibilities include:
*Provide Regulatory Affairs guidance and strategy for project planning
*Managers US and International Regulatory processes for strategic planning and registration documentation
*Prepare 510(k) Premarket Notifications, PMA Supplements, Change Notifications for Design Dossiers as required.
Skills include:
*Bachelors degree with 7+ years of experience
Must have submitted documents to FDA such as 510(k)'s, PMA's and IDE's
*Must have Medical Device Experience
*Must have strong knowledge with FDA regulations and ISO standards
To find out more about Real please visit www.realstaffing.com