About QA / RA Consulting Group
QA/RA Consulting Group is a leader in regulatory and compliance services, specifically supporting the medical device industry, with headquarters in Pittsburgh, PA. With more than 25 years of industry experience, we provide comprehensive and viable regulatory strategies and solutions to companies of every size around the world, from start-up to Fortune 500.
We position our clients for success, through experience, knowledge and guidance. Our mission is to lead your organization forward by providing a strong partnership based on trust, integrity and unmatched client focus. We will provide experience, knowledge and guidance to meet your global quality and regulatory requirements while incorporating exceptional service, value and a balanced business approach. Through an extraordinary work ethic and industry best practices, our consultants will consistently exceed your expectations in pursuit of your established goals.
Our Competencies and Expertise
Our consultants are industry experts in a broad spectrum of devices, technologies, and markets. We work directly with you to develop and implement efficient and cost-effective regulatory strategies and submissions; Quality Management Systems implementation, remediation and maintenance; and risk management strategies.
Our team of consultants has an average of twenty-plus years experience working with disposable and electro-mechanical, sterile, imaging, and software medical devices and IVDs.
Our industry expert consultants have spent much of their careers working on large OEM and start-up, leading-edge, complex medical device projects.
Our team can assist organizations of any size by navigating the ever-changing regulatory hurdles that impede time to market.
What We Do
Our industry expert consultants can augment your QA / RA staff, or help you to establish and maintain your quality management system, throughout the certification or FDA inspection process.
Meet Our Core Team
We provide a full-service global network of highly seasoned Regulatory and Quality Professionals with industry experience. All of our consultants have 17+ years industry experience with FDA Class I, II and III sterile disposables, combination products (Device / Drug / Biologic), software, durable equipment, diagnostics, point-of-care, therapeutic, in-vitro devices and others.
Founder and Principal
Technical Writer/International Affairs Administrator
Join our Team
We can offer you exciting employment opportunities and challenges. We are committed to each individual's success by providing development opportunities to ensure personal career aspirations are met.
QA/RA Consulting Group, Inc. is an equal opportunity employer.
For information regarding employment opportunities at our company please submit your resume/CV to Info@qaraconsultinggroup.com.
People are the key to our success. We promote a culture of individual excellence involving pride, desire to succeed, accountability, teamwork, and follow through.