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.
- RCA -US
- Six Sigma - Black Belt
- Certified Lead Auditor – ISO 13485:2016
Regulatory Compliance Associates® (RCA) provides life science consultants & consulting services to the following industries for resolution of compliance and regulatory challenges:
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. Our life science consultants 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, we 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
- 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 more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
RCA's Pharmaceutical 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, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.
Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and the unique inner workings of the regulatory process.
Whether you're in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, RCA® will guide you through every step of the regulatory process and create a customized approach depending on your product and your pharma company's individual needs. Our clients include:
- Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
- 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 expertise in the remediation of warning letters, consent decrees, 483's or import bans
Regulatory affairs is Regulatory Compliance Associates®’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.
As your partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.
- New Product Support
- Product Lifecycle
- Other Regulatory Services
The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA®, we offer the experience and resources necessary to guide you in quality compliance.
- Regulatory Agency Response
- Preparation and Training
- Inspection Readiness
Regulatory Compliance Associates® Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality life science consultants with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.
- 21 CFR Part 11
- Data Integrity
- Manufacturing Support
- Facility Support
Regulatory Compliance Associates® has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute.
We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA® can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.
- Regulatory Action
- Warning Letter
- 483 Observation
- Oversight Services
The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device's life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA®'s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.
Our team of over 500 life science consultants — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483's, import bans or consent decrees. We offer expertise in a variety of medical fields, such
For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates®, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks.
With a well-planned design, along with full visibility of product development and the supply chain, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.
Regulatory affairs is Regulatory Compliance Associates® 's backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.
As a trusted regulatory affairs consultant, our FDA veterans and industry experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support.
- New Product Approval
- Post-Approval Support
- Outsourced Staffing
- EU MDR
Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it's preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® Inc. can help.
Our network of over 500 FDA, Health Canada & MHRA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.
- Gap Assessments
- Internal Audits
- Employee Training
- Notified Body Response
Regulatory Compliance Associates® Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our life science consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.
In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At RCA®, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.
With more than 20 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry Experts are fully equipped to handle your unique QA needs.
- 21 CFR 210
- 21 CFR 211
- Outsourced Staffing
- Facility Validation
- Equipment Validation
Regulatory Compliance Associates® is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.
Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our unique expertise and experience that makes partnering with RCA® Inc. a competitive differentiator in the remediation space.
- Quality System
- Technical File
- Design History File
- Data Integrity
Whether it's a strategy, a technical plan, or project, Regulatory Compliance Associates® life science consultants can help ensure a successful mix of people and product so your project is on time, on budget, and you're never embroiled in a costly mistake.
Our 500 industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product's development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.
- Manufacturing Optimization
- Product Lifecycle Management
- Mergers & Acquisitions (M&A)
- Due Diligence
- Device Vigilance
- Product Complaints
- Medical Information
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, 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.
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.