Andrea Schrack
Regulatory Affairs
I’m a Regulatory Affairs professional who has spent over 15 years building an internal library of ideas from across domains. This library is a source of guidance and inspiration in the freelance consulting projects I take on, most of which involve Class III implantable medical devices at pre- and post-market stages. The patterns I’ve identified and habits of thought I’ve developed have showed me and my teams the way to many timely approvals, some early enough to break records. These approvals, in turn, have translated into patients receiving safe and effective devices at an earlier point in their lives, the most meaningful outcome of all.
Having worked in-house on new product development at Medtronic and W. L. Gore & Associates, and having served companies such as Johnson & Johnson, Abbott, Olympus, and Boston Scientific via consulting projects, I continue to guide teams through innovation and advancement of their medical technologies with rigorous thinking and direct, diplomatic communication.
I’m also looking to what’s next: Research is accelerating and medical science is on the brink of a new golden age. As new discoveries bring potential rewards and risks at speeds and scales beyond human experience, my goal is to advance my profession’s highest standards in a way that helps unlock the future’s best promises.
Lastly, I’ve got skin in the game: I’m the recipient myself of implantable medical devices, so my drive and enthusiasm run deep. I can’t wait for what’s next.
A list of experience is available upon request to Info@BranchingPaths.LLC.