Twenty years of regulatory affairs experience in Medical Devices, Pharmaceuticals and
In-Vitro diagnostics.  RAC professional with the ability to efficiently organize and streamline regulatory documentation and procedures.

Titles Held: Regulatory Affairs Manager; Product Standard Release Manager; Quality Control/Technical Service Manager; Director of Technical Services; Clinical Laboratory Supervisor

• Proven track record of successful negotiations and strong working relations with FDA (CDRH) for new product introductions and regulatory compliance issues
• Experience with regulatory strategy, reporting, CAPA processes, recalls and field corrections
• Highly skilled at preparing 510(k)’s and Technical Files for CE marking and liaison with Notified Body
• Knowledge of reviewing and approving product labeling, advertising and promotional materials, specifications, research protocols and reports
• Qualified at managing complaint handling systems and investigating all safety-related incidents