Regulatory Compliance Associates team of experienced life science consultants from FDA-regulated industries has navigated the front lines in regulatory affairs, compliance assurance, quality assurance, remediation strategy and support, and strategic consulting. Not only do we understand the complexities of running a life science business, Regulatory Compliance Associates can also negotiate the difficult demands of remediation and compliance with insight, hindsight, and the clear advantage of our unique expertise and experience.
Executive Leadership Team
Erika Porcelli
Chief Executive Officer
As CEO of Regulatory Compliance Associates®️ Inc., the number one focus for Erika Porcelli is customer experience. Coming from a background that has touched all aspects of RCA services, Erika Porcelli values the importance of client relations above all. In...
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Rod Mell
Executive Head, Medical Device Consulting
Rod Mell is a dynamic leader with over twenty-eight (28) years of experience in pharmaceutical and medical device quality management and regulatory. Results-driven, well-rounded experience base across the areas of plant operations, quality systems, regulatory strategy, sustaining engineering and new...
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Arielle Anahory
Global Head of Operations
As Global Head of Operations, Arie oversees the Regulatory Compliance Associates® operations group, driving initiatives to enhance customer satisfaction, project execution and working collaboratively with cross functional-teams to implement strategies that meet and exceed customer expectations. She plays an important...
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Susan Schniepp
RCA Distinguished Fellow
With more than 40 years of industry experience in quality control and quality assurance, Sue has had responsibilities for complaints, labeling, investigations, compendial affairs, and other quality systems. In addition to RCA, she has held leadership roles at Allergy Laboratories,...
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Krista Kurth
Controller
Krista Kurth has more than 20 years’ experience in accounting and project management. She joined Regulatory Compliance Associates® Inc. as the Director of Accounting in 2012 and was promoted to Controller in November 2016. As Controller, Krista Kurth oversees the...
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Beth Edick
Manager, Talent Management
Beth joined Regulatory Compliance Associates in 2021 as Manager, Talent Management. Bringing more than 20 years of experience in the Life Sciences sector managing national recruiting teams, she is an incredibly valuable asset to the team. Beth is responsible for...
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Client Experience
Balazs Vandor
Director, Operations and Client Experience
Balazs Vandor has over 20 years of proven expertise in project management, cGxP, familiarity with all functions of the organization, and the ability to quickly establish positive working relationships at all levels. As a Director of Operations and Client Experience...
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Margaret Harvey
Director, Operations and Client Experience
Margaret Harvey has over 15 years of proven expertise in all stages of project and program management with a proven history of driving and communicating strong solutions that bridge the gaps between business & technology. As a Director of...
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Justin Anahory
Operations Specialist
As an Operations Specialist for Regulatory Compliance Associates®, Justin helps support for finance, program/operational managers and RCA leadership by: assisting in the development and maintenance of project schedules, providing detailed task-orientated project and budget reports and executing various other job...
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Gina Desimone
Operations Specialist
Gina has over 20 years of progressive involvement across a broad range of project management functions and diverse industry segments. She joined Regulatory Compliance Associates® as a Operations Specialist in 2022. As an Operations Specialist, Gina provides support for finance,...
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Client Relations
Tayl’r Hollis
Sr. Director, Client Relations
Tayl’r Hollis has over 10 years of experience with a reputation for managing and growing successful client relationships. Over 6 of those years have been in the life sciences industry. As Sr. Director of Client Relations for Regulatory Compliance Associates®...
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Elizabeth Morack Tews
Sr. Director, Client Relations
Elizabeth Morack-Tews has more than 15 years of business development and sales leadership experience. As Regulatory Compliance Associates® Sr. Director of Client Relations, she will be responsible for acquiring new business opportunities and building strong, client-focused, relationships. Elizabeth Morack-Tews has...
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Brandon Miller
Sales and Marketing Coordinator
As the Sales and Marketing Coordinator for Regulatory Compliance Associates® Inc., Brandon Miller interacts with sales and operations, and is responsible for ensuring that all marketing collateral and other communications reflect RCA’s branding guidelines. Brandon Miller assists the VP of Client...
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Subject Matter Experts
Steven J. Lynn, MS
Executive Principal Consultant, Pharma and Biologics
Steve has over twenty (20) years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma, and tissue industries. He is an expert in Current Good Manufacturing Practices (CGMP) compliance-related matters and has significant experience with other...
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Anita Michael
Executive Principal Consultant, Pharma Compliance
Anita has 24+ years of global regulatory and quality experience, including 16 years’ operating globally as a Pharmaceutical Expert, FDA Investigator and FDA Pre-Approval Manager. She specializes in preparation, remediation and designing of training for individuals at all levels of...
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Rona LeBlanc-Rivera, Ph.D.
Principal Consultant, Regulatory Affairs
Rona has over 23 years of experience spanning the FDA and the pharmaceutical industry. She served as an FDA reviewer in chemistry, manufacturing and controls for biologics and generic drug applications, a regulatory affair professional, and as a pharmaceutical industry...
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Jordan Elder
Director, Regulatory Affairs
Jordan Elder has almost 15 years of experience navigating regulatory pathways and identifying optimal regulatory strategies for both pharmaceutical and medical device companies. As Regulatory Compliance Associates® (RCA) Director of Regulatory Affairs, he is responsible for providing our clients with...
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Michael Miller
Director, Quality Systems
Michael Miller has over 30 years of expertise in the medical device industry. Demonstrated experience in Leadership, Program Management, and Quality Systems Development. Recognized for solving complex issues and developing strong relationships. His areas of expertise include design control, corrective and...
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Larry Servi
Director, Program Management
Larry Servi has 30+ years’ experience leading medical product development and engineering. His areas of expertise include project management, portfolio analysis and planning, design control, risk management, CAPA management and investigations, problem solving, and materials and process engineering. At Regulatory...
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Jessica Schafersman
Subject Matter Expert, Design Controls
Jessica Schafersman is a Biomedical Engineer, Project Management Professional, and Certified Usability Analyst, with more than 20 years of experience in medical product development, combination products, sterile implants, sterile disposables, capital equipment and instrumentation spanning Class I, II, and III...
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