Charlotte Baker, RAC, PMP, serves as the Senior Director, Regulatory & Strategic Development, Medical Devices.Please join us in welcoming Charlotte Baker to the Clinipace family! Baker, RAC, PMP, serves as the Senior Director, Regulatory & Strategic Development, Medical Devices. She brings more than 20 years experience in regulatory, quality and compliance in the healthcare, biopharma and medical device industries. Baker also has a proven track record in leading and achieving successful global product submissions/approvals for new products and post-commercialization changes (PMA & 510k).

In this role, Baker is responsible for developing regulatory strategies for client products. She also prepares regulatory submissions for the US FDA, EMEA and other regulatory authorities.

Prior to Clinipace, Baker served as a consultant for Sandoz, acting as the US agent to the FDA (District & Center) and representing all of Sandoz and third-party market authorization holders/licensing agreement partners for Field Alert Reporting & Recall Management. She also provided premarket submission strategy and support to medical device manufacturers. She has also served as the Senior Manager, quality compliance, at Amgen and the Senior Manager, Regulatory Affairs, at Covidien.

Trained as a microbiologist, Baker has experience in many therapeutics areas, including oncology, orthopedics, cardiology, endocrinology, diagnostics, imaging, combo devices, infectious disease, respiratory, and more.

Baker has hit the ground running in her new position. In fact, she recently spoke at an Innosphere Lunch & Learn in Fort Collins, CO. Innosphere is a nonprofit technology incubator formed to accelerate the development and success of high-impact scientific and technology startup companies. In her presentation on medical device commercialization in the US, she discussed basics such as what is and isn’t considered a medical device, device classifications, the FD&C Act and CFR basics, quality system requirements, as well as how to understand the foundations for developing a regulatory pathway for a product, Quality System Regulation (QSR), which provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures.

We look forward to sharing more of her expertise with you in the upcoming year. If you’d like to be alerted when registration for our next medical device webcast begins, please leave your contact information in the comments section. Until then, please take a look at our medical device resources page.