Principal Regulatory Affairs Specialist

A growing medical device company seeking to improve the safety and reduce the cost in healthcare is seeking a principal regulatory affairs specialist to join their team. The principal regulatory affairs specialist will work on domestic and international submissions for product lines including infusion, ventilators, respiratory diagnostic instruments, devices for interventional procedures, and/or surgical equipment.

The principal specialist will:

-Develop regulatory strategies, domestic and international.
-Prepare, submit and maintain domestic and international submissions (CE Mark, 510k, etc.)
-Act as regulatory affairs representative on core team for development projects.
-Review product design and change documentation.
-Review domestic and international labeling for compliance to labeling requirements, including content, format, etc.
-Review and approve product risk assessments.
-Provide regulatory guidance as needed.

Qualifications:

-3+ years regulatory affairs experience
-Knowledge of U.S. [FDA 510(k)] and International regulatory requirements
-Knowledge of ISO / MMD
-Bachelor's Degree

To find out more about Real Staffing please visit www.realstaffing.com