Nancy Sauer Email & Phone Number

Colorado, United States

Responsible for regulatory strategy and compliance in the Surgical Innovations Operating Unit of Medtronic.

Boulder, Co

I oversee a team of talented regulatory affairs specialists focused on bringing new energy-based surgical products to the market. I also participate in regulatory advocacy through the AdvaMed 510(k) working group.

Boulder

I work with product development teams to plan the appropriate regulatory strategy for the U.S. and around the world. I also prepare 510(k) submissions and STED documentation. I am currently involved with multiple product lines including electrosurgical generators, electrosurgical instruments, and ultrasonic surgical systems.

Working with product development teams to establish and implement regulatory strategies. Participating in the AdvaMed 510(k) Working Group and other advocacy activities. 510(k) submissions and CE marking of new and changed devices. Participating in risk management board and cyber security community of practice.

My responsibilities are twofold. I ensure that the Evergreen Research stays in compliance applicable regulations and ISO standards.I also provide regulatory advice and services to ERI clients and outside companies. Typical projects includeQuality system auditsQuality system developmentDefining regulatory strategiesPreparing various medical device submissions, including traditional and special 510(k)s, CE mark documentation, and other international submissionsMonitoring and oversight of clinical studies

RDD Consultants provided regulatory affairs and technical documentation services, specializing in small to medium-sized companies. As head of regulatory services I prepared successful U.S. and international medical device submissions for a variety of products. When needed, I developed and managed clinical studies to support the submissions. RDD Consultants was one of the initial Third Party reviewers approved by FDA, which gave me valuable insight into the review process.

Ma, Mcd Biology

Research activities included classic and molecular genetics, cell culture, and immunoassays.

Ba, Biology And French

Activities and Societies: Phi Beta Kappa