Anike has held a unique combination of regulatory affairs-related roles in her 15-year career. She began her 11-year tenure with the U.S. Food & Drug Administration (FDA) as a research fellow; eventually becoming a Lead Reviewer in the Dental Devices Branch, and Senior Consumer Safety Officer in the Division of Industry and Consumer Education (DICE).

It was during her time in DICE that she engaged with hundreds of medtech professionals; helping them understand various pre- and postmarket regulatory requirements through 1-on-1 conversations, educational web content, and conference presentations. She found satisfaction in helping others learn what they needed to reach their goals.

After several years in industry as a medical device consultant and, later, Regulatory Affairs Manager at Thermo Fisher Scientific, Anike realized medtech companies of all sizes have the same types of problems. The key to solving them was not just knowing regulatory requirements but acknowledging business priorities and limitations, getting creative, and becoming comfortable with the ever present “it depends” nuance of regulatory affairs to reach logical, actionable conclusions.

If you feel overwhelmed or behind, Anike is happy to help! In working with her you may find you are more capable than you originally thought.

Anike holds both Bachelor’s of Science and Master of Engineering degrees in Bioengineering from the University of Maryland - College Park. She enjoys running and baking; interests that conveniently cancel each other out calorically.