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 general direction, tactical objectives, and functional plans for their regulatory needs.

Jordan Elder is a meticulous regulatory professional with a comprehensive background in medical device regulations and a demonstrated history of successful product submissions including; FDA 510(k), EU Class IIa and IIb, Health Canada Class III, COFEPRIS Class III, and CFDA Class III submissions. He is an effective leader in managing regulatory teams within a global matrix organization and proficient at maintaining positive working relationships with regulating bodies.

Jordan's Certifications

• RCA -US
• Six Sigma - Black Belt
• Certified Lead Auditor – ISO 13485:2016

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 preventive action (CAPA), product lifecycle, and change control.

As a quality subject matter expert at Regulatory Compliance Associates^®, Michael Miller assist our clients on and off site with quality needs. He leads RCA's internal team in developing quality systems compliant to ISO 9001 and has worked with an outside consulting team to support RCA in obtaining ISO 9001 certification.

Additionally, he is recognized for solving complex product issues and developing strong relationships with customers, manufacturers, and suppliers.

Formerly at Baxter, Mike holds a Master of Business Administration from DePaul University in Chicago, Illinois, and a Bachelor of Science in Industrial Technology from Southern Illinois University. Mike lives in Lake Villa, Illinois, not far from the Wisconsin border.

General Manager and Subject Matter Expert

Dr. Stephen Coulter is a business-focused leader heavily grounded in technology.  He has over 40 years of proven success in leading product development organizations (global as well as small start-up) through commercialization with a focus on quality assurance and compliance excellence.

As Regulatory Compliance Associates’® General Manager and Subject Matter Expert, his responsibilities include support for biomedical product, medical device, combination product, over-the-counter (OTC) drug, nutritional, consumer and environmental product companies in the areas of compliance with 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, and ISO 10993; development of Quality Management Systems; remediation of legacy products; resolution of internal and external audit findings; lifecycle management; product support; sustaining engineering; product development; and staff or management training.

Dr. Stephen Coulter’s areas of expertise include product development, design control, design transfer to manufacturing, technology partnerships, product lifecycle management, portfolio management and acquisition analysis.  He is experienced in the development of manufacturing process controls and quality levels for critical processes or products.  He also successfully aligned development, quality and compliance organizations within companies to establish and sustain regulatory compliance to United State and international medical device regulations.

Steve’s regulatory affairs and quality assurance experience includes preparation of design history files or technical files for regulatory submissions.  He has also participated in company advocacy efforts with federal agencies, congressional personnel, and public health groups.

His fields of technical experience include polymer synthesis:  urethanes, silicones, acrylics, rubbers (latex and synthetic), epoxies, hydrogels and biodegradables.  He also has experience with polymer processing including molding, latex dipping, extrusion, coatings and composites.  Other technical areas of expertise include surface modification methods for improved compatibility, microbicides and antibacterial treatments; natural products and herbal formulations for consumer products; and sensor development (e.g., critical care cardiac, consumer in vitro diagnostics, immunochemical and environmental monitors.)

Steve is a noted published author, exceptional presenter, and holder of multiple patents who has established and participated in patent activities (patent committees, intellectual property management), executed and managed technology assessment activities including confidentiality and licensing agreements, due diligence efforts (technical, regulatory and compliance) and technology partnership programs with entrepreneurs and academia.

Steve has a joint Ph.D. in Macromolecular Science and Engineering, and Organic Chemistry as well as a Master of Science in Chemistry from the University of Michigan.  He has received numerous awards and appointments.  Steve is a resident of Palm Desert, California.

About RCA's Pharmaceutical Consulting Services 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates^® offers leading pharmaceutical consultants. We're one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It's a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

Client Solutions

Whether you're in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company's individual needs. Our regulatory compliance clients include:

• Companies new to FDA, Health Canada or EU regulations and regulatory compliance
• Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
• Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
• Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483's or import bans

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

• New Product Support
• Product Lifecycle
• Other Regulatory Services
• Combination Products

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

• Assessments
• Audits
• Regulatory Agency Response
• Preparation and Training
• Inspection Readiness
• Data Integrity

Quality Assurance

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

• 21 CFR Part 11
• Data Integrity
• Manufacturing Support
• Facility Support
• Quality Metrics

Remediation Services 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We'll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

• Regulatory Action
• Regulatory Compliance
• Regulatory Enforcement
• Warning Letter
• 483 Observation
• Oversight Services
• Risk Management Plan

About Regulatory Compliance Associates

Regulatory Compliance Associates^® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

• Life Sciences
• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

• Founded in 2000
• Headquartered in Wisconsin (USA)
• Expertise backed by over 500 industry subject matter experts
• Acquired by Sotera Health in 2021

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health^®.

Sotera Health Company, along with its three best-in-class businesses – Sterigenics^®, Nordion^® and Nelson Labs^®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Commitment to Quality

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

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 Compliance Associates^® Inc., Larry Servi provides consulting services to the pharmaceutical, biotechnology, and medical device industries. This includes leading assessments in various areas of quality systems and design control and devising and leading remediation programs. Larry also has provided his project management expertise to clients looking to outsource engineering or product development programs.

Prior to RCA, Larry was at Covidien, Baxter, and Parker Hannifin, where he initially specialized in polymer development and process engineering and then transitioned into medical device and combination product engineering. He has launched over a hundred new products and holds four United States patents.

Larry holds a Master of Science in Engineering Management and a Bachelor of Science in Chemical Engineering from Northwestern University. He received his PMI certification as a Project Management Professional in 2005. Larry lives in the Chicago suburb of Hawthorn Woods.