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Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory affairs professionals are a critical element in the medical device development process, but are often overlooked for their impact to business and product development strategy. The most efficient, cost-effective and compliant way to get medical devices to market worldwide is to involve regulatory affairs early and in every aspect of a medical device’s lifecycle.
Although hard to believe, there was a time when medical devices could be developed without any government oversight. Recently, strategic regulatory affairs input has become just as important as how your device is designed, manufactured and marketed. The new regulations have changed the RA professional's role and have transformed the relationship between regulatory affairs and every other department within a medical device organization.
This webcast will demonstrate how the RA professional is a key strategic player starting with premarket planning and continuing through product development stages, manufacturing, and post market activities, and review best practices for engaging cross functionally for positive impacts across business groups.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Upon conclusion of the program, you will be able to:
Who Should Attend?
Susan Speicher, MS, RAC, Director, Regulatory
Affairs, Network Partners
As Director of Regulatory Affairs, Susan brings over 19 years of medical device industry knowledge across engineering, quality and regulatory affairs to the Network Partners team. In her role, Susan leads a team of regulatory professionals who provide a range of regulatory affairs services to clients including regulatory strategy, submission authoring and regulatory project leads while supporting business development initiatives.
Susan is RAC certified and specializes in the medical device products industry for the US, EU and Canada. She began her career as a medical device mechanical engineer with Bayer HealthCare (formerly Medrad, Inc.) and has served in several regulatory affairs and quality systems management roles with Bayer HealthCare, Omnyx, LLC (part of GE HealthCare) and PECA Labs.
Susan holds a MS and BS in Mechanical Engineering from the University of Pittsburgh.
Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.