Personnel

Mitch Januszewski
Mitch Januszewski is the President of Regulatory Compliance Associates Inc.  Mitch has more than 25 years of experience in FDA regulated industries and over 15 years of experience consulting regulated companies. Prior to forming Regulatory Compliance Associates Inc., Mitch served as the President and CEO of Oak Grove Technologies Inc. His areas of expertise include compliance strategy development, quality systems implementation, warning letter remediation, process management, validations, compliance audits, pharmaceutical utilities design, and project management. Mitch also has taught courses in Design and Validation of Pilot Manufacturing Facilities for ISPE and Regulatory Compliance in Bulk Chemical Manufacturing for the Pharmaceutical Industry for AICHE conferences.

Steven Schultz
Steven Schultz is the Executive Vice President of Regulatory Compliance Associates Inc.  Steve has more than 25 years of experience in FDA regulated industries and almost 10 years of experience consulting regulated companies. Prior to forming Regulatory Compliance Associates Inc., Steve held many positions within Pharmacia, including Validation Manager, Mechanical Engineer, Project Manager and Facility Operations Lead.  His areas of expertise include validation, compliance auditing, facility and mechanical systems, HVAC controls and automation, process management, integrating compliance and good business practice, and project management. Steve has also taught many courses on Green Building Strategies and Sustainable Development in Lab Design.

Mike Parkes
Mike Parkes is the Chief Operating Officer of Regulatory Compliance Associates Inc.  Mike has more than 30 years of experience in FDA regulated industries. Prior to joining Regulatory Compliance Associates Inc., Mike served as Vice President of Parenterals Quality Operations at Hospira, Inc. Mike has a proven track record of results operating in both large and small organizations.  He has had extensive interface with the FDA, at district and headquarters levels, as well as with international regulatory authorities. His areas of expertise included quality management, manufacturing and plant operations, regulatory compliance, project management, and lean manufacturing practices.

Mike Scharf
Mike Scharf is Vice President, Medical Device and Pharma/Biotech Practices of Regulatory Compliance Associates Inc. Prior to RCA, Mike spent over 27 years in product and technology development at Baxter Healthcare Corporation in both divisional and corporate engineering leadership roles, and most recently was Director of Engineering for BioScience Cellular Therapies. Mike participated in leadership as well as hands-on roles including innovation in the areas of  medical devices, specialty delivery containers for autoclavable and aseptically filled pharmaceuticals, autologous stem cell processing, and is listed as an inventor on 11 U.S. Patents. Mike is highly knowledgeable and experienced with project management, design control, structured problem solving and root cause analysis and has directed multiple engineering teams in the areas of product and process validation, complaint handling, CAPA execution and compliance, and Design History File risk-based remediation.  Mike has a Bachelor of Science degree in Bioengineering from the University of Illinois at Chicago.

Jim Bedford
Jim Bedford is Vice President, Technology and Mergers & Acquisitions Practices at Regulatory Compliance Associates Inc. Jim has developed extensive experience in healthcare mergers and acquisitions over the past 29 years working for companies including: Baxter Healthcare Corporation, Caremark, and Bearing Point Inc.  He has served in a variety of quality, operations and marketing functional roles. Jim has executed numerous business development acquisitions in over 7 different countries, which has given him significant international experience. He has a reputation for providing strategic, M&A, and divestiture direction to maximize business potential and produce long term results for every company in his portfolio. Jim has a Bachelors in Pharmacy from Purdue University, and has post graduate business school studies at Northwestern University, University of Chicago, University of Virginia, and Yale University.

Kim Januszewski
Kim Januszewski is the Chief Financial Officer of Regulatory Compliance Associates Inc.  Kim has more than 18 years experience in FDA regulated industries.  Prior to forming RCA Inc., Kim served as Operations Director for Quintiles Consulting.  Kim has served as a Director of Clinical Supply Group for four years at Quintiles as well as performing GCP Audits.  Kim holds a Biology degree from University of Virginia.