content contibutor robert michalik

Robert Michalik, JD, RAC

RegulatoryPro Consulting

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

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Working with the FDA: Medical Devices and Regulatory Touchpoints 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.

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Clinical Research Associate (CRA) Clinical Research Associate (CRA)
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This role-based course provides the practical know-how to monitor clinical research sites effectively.

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