Steven Schultz


Principal


Steve Schultz developed his career in life sciences with roles such as Validation Manager, Mechanical Engineer, and Sustainability and Energy Manager. After about 25 years in the industry, Steve launched Regulatory Compliance Associates® Inc. (RCA) with Mitch Januszewski in 2000.

For Steve, starting a consultancy firm was a natural extension of his belief that regulatory compliance greatly contributes to the overall health of life science companies. Since then, Steve has impacted hundreds of such companies, providing them with strategies and tools. His focus has been on helping clients to realize that regulatory compliance is obtainable and emphasizing that a compliance strategy should not rely on hope alone.

Steve’s areas of expertise include QL, compliance auditing and inspections, validation strategy, facility and mechanical systems compliance methods, energy efficient and sustainable design strategies, process mapping, project management, auditing gap analysis, risk assessment, and remediation planning and implementation.

His accomplishments include leveraging compliance strategies to create best business practices to be used as a competitive advantage and the development and implementation of RCA strategies including a risk-based approach using failure mode effects analysis (FMEA) for pharmaceutical manufacturing, R&D, biotechnology, and medical device applications.

Steve earned a Bachelor of Arts in Organizational Communications from Roosevelt University in Chicago, Illinois. He resides in Bristol, Wisconsin.

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