Candice Bautista Biddle
About Candice Bautista Biddle
Candice Bautista Biddle is the Regulatory Affairs Program Manager at Cleerly, specializing in AI/ML-based Software as a Medical Device and US FDA regulations.
Current Role at Cleerly
Candice Bautista Biddle serves as the Regulatory Affairs Program Manager at Cleerly. She began this role in June 2021. Her work focuses on managing regulatory strategies and ensuring compliance with US FDA regulations, particularly in the context of AI/ML-based Software as a Medical Device (SaMD).
Previous Experience at Medtronic
Candice Bautista Biddle worked at Medtronic as a Senior Regulatory Affairs Specialist. She held this position from 2017 to 2021, during which time she spent three years and seven months in Boulder, Colorado. Her role involved overseeing regulatory compliance and engaging with various regulatory bodies.
Regulatory Affairs Internships
Candice Bautista Biddle gained early career experience through internships in regulatory affairs at Biogen and Alkermes. At Biogen, she worked as an Advertising and Promotion Intern in 2017. She also completed a one-month internship at Alkermes in Waltham, MA, in 2016, focusing on regulatory affairs projects.
Educational Background
Candice Bautista Biddle holds a Doctor of Pharmacy (PharmD) from Massachusetts College of Pharmacy and Health Sciences, completed between 2014 and 2017. Prior to that, she earned a Bachelor’s Degree in Neuroscience from Brandeis University, where she studied from 2010 to 2014. She also attended Stuyvesant High School from 2006 to 2010.
Specialization in Regulatory Affairs
Candice Bautista Biddle specializes in regulatory affairs, with a particular focus on AI/ML-based Software as a Medical Device (SaMD). She is well-versed in US FDA regulations, drawing on her extensive experience in the field to guide her strategies and ensure compliance in her work.