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
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
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:
See where you can provide strategic support to
product development teams
Understand how to engage with cross functional
teams on regulatory efforts
Brainstorm strategic regulatory solutions
Who Should Attend?
- Mid-career RA professionals
- Those looking to understand how to engage with
product development teams
- Members of product development teams looking to
understand the importance of the regulatory affairs professionals on their team
- 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.