Paula Gray is an associate director in the Life Sciences Regulatory, Quality and Patient Safety organization. Paula has 25 years of experience supporting companies operating in the device, diagnostics, and combination product spaces in regulatory compliance and quality systems. She has particular expertise in design and development activities for combination product manufacturers wishing to comply with U.S., European, and international standards and regulatory requirements for medical devices.
As a quality expert, Paula has developed, implemented, and maintained processes within quality management systems, and has particular experience in investigating, resolving and mitigating product non-conformances. She also has experience in document control, design controls, human factors, software compliance, risk management, complaint handling, adverse events, and corrective and preventive actions.
In the regulatory arena, Paula has experience with reviewing records for and preparing regulatory submissions for both stand-alone medical devices and combination products containing a medical device constituent part. This includes identifying regulatory submission strategies, discussing such strategies with U.S. FDA, and responding to any questions or requests during the review of regulatory submissions.