Description
Well known medical device company in New Jersey is looking for a Regulatory Affairs manager. the role will include management of both the regulatory Affairs and Quality departments. This is a 6 month contract that has potential to become a permanent position.responsibilities include:
-The role require you to Maintain the company's regulatory affairs and quality management system at a functional and compliant level.
-Prepare regulatory submission documents and technical documentation necessary for product approvals, marketing authorizations and, as needed, other authorizations worldwide.
-Prepare operational and capital budget plans
-Coordinate the compiling and submission of product approval and/or marketing authorization submissions on a worldwide basis
Skills:
-6+years of medical device experience
-experience with Class II,III medical devices
-Experience with Regulatory submission - 510K, PMA
-Experience with Electromechanical devices
-experience managing direct reports
-understanding of design control, technical files
To find out more about Real please visit www.realstaffing.com