Tracey Fox Email & Phone Number

Waukesha, Wi, Us

Developed the regulatory component of a foundational compliance program to evaluate, support and remediate medical device products across the enterprise. Educated executives and program management on medical device regulations. Influenced to ensure compliance with products developed both in house and by vendors. Provided regulatory strategy for a broad range of devices including biometric remote patient monitoring, Software as a Medical Device (SaMD), Artificial Intelligence (AI/ML), and Clinical Decision Support (CDS).

Led a global team of medical device regulatory experts to support medical device submission into markets such as Singapore, Australia, Canada, Europe, and China. Supported MDSAP and regulatory requirements for US, Brazil and Japan. Involved with influencing and trade associations to ensure knowledge of new regulations, standards, and guidance. Implement EU MDR (Medical Device Regulation) policies and procedures. Key member of executive team on partnership contracts. Provided support for the Life Sciences Quality Management System.

Hartland, Wi

Enabled global growth through market expansion for the current software medical device portfolio. Supporting R&D by developing regulatory strategies to reduce time to market. Established compliant procedures to allow for a successful MDSAP audit.

Led a team of RA professionals supporting the Global Service business of GE Healthcare. Provided RA Strategy for new products and offerings across a diverse space of medical devices, software, non-medical devices, and field service. Involved in trade associations, acquisitions, promotional material, and procedure development.

Premarket Regulatory including strategy for new product introductions, 510(k) submissions and Pre-IDE submission. Review of promotional material. Authoring global regulatory procedures and developing regulatory training materials.

Managed curriculum and delivered Six Sigma training Mentored Blackbelt and MBB projects throughout the business. Benchmarked external companies. Worked as part of an acquistion integration team.

Managed the launch of Corporate compliance and ethics policies globally. Involved with US Customs audit. Led annual compliance review process. Replaced an aging Complaint Management System. Created and managed regulatory and compliance metrics. Handled Postmarket Regulatory Reporting.

Led cross-functional teams of Greenbelts and Blackbelts through several cost saving projects.

Managed the Quality System at the GE X-ray tube site. Hosted FDA inspections and external audits. Integrated compliance to new FDA requirements in new products. Led a strong self audit team.

Implemented QS9000 at the site. Direct contact for international customer issues. Responsible for all quality documentation including control plans, FMEAs, and submissions. Implemented automated test equipment.

Developed submission packages for automotive supplied parts including creating test plans and procedures to meet design specifications. Integral member of new products team.

Masters, Regulatory Affairs

Bachelors, Industrial Engineering