content contibutor robert michalik

Robert Michalik, JD, RAC

RegulatoryPro Consulting

Robert Michalik is an FDA regulatory attorney and founder of RegulatoryPro Consulting, a firm providing general and specialized services to the biopharmaceutical and medical device clients. Mr. Michalik has over 30 years’ experience working in the biopharmaceutical and medical device industries, and earned degrees in biochemistry (BS) and law (JD). He counsels clients in range of technical, quality and regulatory areas relating to new product development and commercialization activities. For over ten years, he was an Instructor and course developer in Northeastern University (Boston, MA) Master’s Degree Regulatory Affairs program.

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Working with the FDA: Medical Devices and Regulatory Touchpoints

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This webinar discusses practical and strategic approaches to interacting with FDA during medical device development.

Working with the FDA: Medical Devices and Regulatory Touchpoints