One of the key strengths of Regulatory Compliance Associates Inc. is its consistent ability to offer the services of top talent. With strong technical backgrounds, our team members are carefully chosen for each project, ensuring that their skill sets match the specific requirements of each job. The consolidation of staff skills and experience represents a valuable, comprehensive knowledge base that we draw from extensively for the benefit of our clients.
Management
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 at 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.
Brian Matye
Brian Matye is Senior Director of Operations at the Regulatory Compliance Associates Inc. Southeast Regional office located in Tampa, Florida.
Prior to RCA, Brian has spent over 25 years of experience in all phases of high reliability systems and medical product development and deployment. Brian’s career has included senior engineering leadership roles with Medtronic, GE Healthcare and most recently with Baxter Healthcare Corporation. Brian has experience in all lifecycle phases of medical device development and has taken programs from concept to market. Brian has demonstrated abilities in project management, interdepartmental coordination, process definition, and quality assurance. Brian is a highly skilled problem solver with excellent interpersonal skills. Brian has a Bachelors of Science from University of Wisconsin – Superior, and a MBA in Operations from Carlson School of Business at the University of Minnesota.
Sarah Wood
Sarah Wood is Associate Director of Quality Audits and Training at Regulatory Compliance Associates Inc.
Sarah is responsible for managing and conducting third party audits as well as the development and implementation of quality systems and training for RCA's Pharmaceutical, Medical Device and Biotech clients. Sarah is instrumental in ensuring our client projects meet strict industry standards. Before joining Regulatory Compliance Associates Inc. in 2007, Sarah worked in the pharmaceutical and biotech industries for a diverse range of organizations, including Invitrogen, PPD and Abbott Laboratories. She recently was a guest of the Government of Shunde China, where she was asked to speak on the topic of “How to Survive & Thrive in a Global Recessionary Environment – A Relentless Focus on Cost and Quality”, at their annual conference. Sarah has a Bachelor of Science degree in Medical Microbiology and Immunology from the University of Wisconsin-Madison and is a Certified Quality Auditor from the American Society for Quality