An “eggciting” event at Cook MyoSite

On September 12, the Regulatory Affairs (RA) directorate at Cook MyoSite hosted their inaugural Regs and Eggs event. RA came up with the idea as a friendly way for employees from other teams to freely ask questions related to the recently formed directorate, submissions, daily functions, and/or current open positions. Attendees were greeted by a hot breakfast prepared by RA. While eating, guests viewed slides personalized by each RA member, containing content such as birth dates, alma maters, and the egg preparation that best aligned with each of their personalities. A Regulatory Roundup session was held in which the RA team fielded a variety of questions from participants.  Attendees then put their newly gained RA knowledge to the test in a trivia challenge titled “So you think you’re an eggs pert?” Questions ranged from “What is the projected date for the Biologics License Application (BLA) submission?” to “Which RA members have lived in the state where Cook is headquartered?” The winner was awarded a lunch with RA, allowing them to further familiarize themselves with the team.  Overall, Regs and Eggs was the perfect mix of personal and professional engagement!

“It was a fun event that incorporated lots of great information about the department and regulatory functions. You can tell that each member of the team put forth a tremendous effort to making it an enjoyable and welcoming breakfast for everyone!” said Carly Duddy, MyoSite Quality Control team lead.

“Regs & Eggs is a perfect example of how we can all make our areas of expertise fun, engaging, and accessible to the rest of the company. Kudos to the entire team for putting on an amazingly creative and informative event!” said Lindsy Bartoleit, MyoSite Marketing manager

A little more about the team
The RA directorate at Cook MyoSite, which is located in Pittsburgh, officially formed in October of 2017. A “directorate” is a grouping of departments that have a similar function. For example, the Quality directorate may consist of the Quality Assurance, Quality Control, and Quality Engineering departments working to perform the quality function of an organization. Leading the RA team is Director Stephen Westover, who has been a part of MyoSite since 2003.  Over the last year, Stephen has welcomed four new members. Among those new members is Regulatory Operations Manager Brett Snyder. While being new to RA, Brett is no stranger to MyoSite as she was previously a part of the Quality Assurance (QA) team for several years and serves as the Ethics & Compliance representative. She currently oversees the Regulatory scientists—Takuma Tsukahara and Marcy Guerra. Takuma previously worked for Cook Medical for 10 years and continues his device-oriented work at MyoSite. Marcy is new to the Cook family and presently leads the authoring of scientific material for regulatory submissions. In addition to new members, an exciting RA role, Regulatory Surveillance scientist, was created and has been filled by Jim Banko, former MyoSite QA member. Jim’s responsibilities in this role include keeping the company up-to-date on new regulations from across the globe.

The RA team is looking forward to another exciting growth spurt in the near future!