Vice President of Regulatory & Compliance
As the Vice President of Regulatory & Compliance for HIPAA VIDEO, Roger Greenwald has many responsibilities. He is predominantly responsible for providing product design assistance, implementing quality management systems, and conducting internal and supplier audits. In addition, he remediates FDA and international regulatory deficiencies for clients.
Roger is a principal at NJK & Associates, Inc. He specializes in troubleshooting and root cause analysis. He is actively involved in training, and audit remediation as well. Roger also teaches clients the letter and intent of the regulations to facilitate the achievement of business and regulatory success.
Roger works with a team of talented professionals at NJK & Associates, Inc. They have been providing engineering, quality, and regulatory services to medical device and in-vitro diagnostic companies worldwide since 2005.
Roger is incredibly skilled at making complex systems and processes understandable to others. Before launching his consultancy, Roger had a career spent in product design, manufacturing, and quality for large and small companies. Roger holds an undergraduate degree in physics and a graduate degree in optics. He has worked in the design and manufacturing of medical devices for 40 years.
He also holds 54 US patents, mostly for medical devices.