Our People

Chad joined Oriel STAT A MATRIX in January 2016 and has served as President of the company since January 2021. He provides the overall business leadership for Oriel STAT A MATRIX’s consulting and education services, with a focus on strategic planning and managing Oriel STAT A MATRIX’s key client relationships, partnerships, and global deployments. Chad is committed to maintaining the company’s heritage of serving our clients with industry-leading competency development capabilities while providing the skilled quality and regulatory resources needed to successfully design, develop, manufacture, distribute, and support high-quality medical devices.

Chad’s experience in life sciences quality management systems and regulatory compliance spans over two decades and includes quality, regulatory compliance, technical, and leadership roles at companies such as Medtronic, Boston Scientific, and Guidant.

Kate Leith has over 30 years of technical and management experience in medical device, IVD, and biologics industries with expertise in quality, program management, training, auditing, and regulatory support.

Her experience spans the entire product life cycle, from design to postmarket. As EVP for Oriel STAT A MATRIX, Kate oversees the technical aspects of the business, providing strategy and managing execution for our portfolio of services.

Sarah joined Oriel STAT A MATRIX in 2015. Since that time, she has worked with a wide range of clients to help them achieve their global RA/QA objectives. With a focus on supporting manufacturers to develop sound strategies for bringing products to market as well as strengthening ongoing compliance initiatives, Sarah takes a client-focused approach to ensure the needs of all stakeholders are accurately captured. As SVP of Business Development, Sarah provides leadership to the business development team. In this capacity, she ensures that the team provides best-in-class support to Oriel STAT A MATRIX’s clients as the global RA/QA environment continually evolves.

Sarah holds a Bachelor of Science degree with a triple major (Molecular Biology, Microbiology, Genetics) from Monash University and an MBA from Texas State University. Sarah has almost 20 years of experience ranging from laboratory science and R&D to tertiary education and professional services sales.

Alicia has over 20 years of experience in bringing Class II and III medical devices and IVDs from concept through to commercialization.

Expert in developing aggressive, creative and proven clinical/market approval strategies and negotiations by leveraging new regulatory programs with regulators in written, verbal and face to face settings. Demonstrated strong leadership of high functioning regulatory, cross-functional and interdepartmental teams to drive the approval of new products to global markets. Extensive experience implementing Company policies, processes and procedures that transform Regulatory Operations and organizational interfaces. Specializing in leading teams that increase collaboration across functional organizations (esp. technical, clinical, manufacturing, labeling, legal and marketing). Highly skilled at identifying and solving complex regulatory and organizational challenges that hinder approval of global market applications. Demonstrates passion for building functional human systems within the context of organizational effectiveness.

Richard brings more than 30 years of global medical device, IVD, and pharmaceutical quality and regulatory experience to each customer engagement, employing his extensive expertise in regulatory strategy, regulatory classifications and submissions, risk management, software-driven products, postmarket surveillance, complaint handling, adverse event reporting, inspection readiness, and auditing.

As the key leader in global regulatory affairs for Oriel STAT A MATRIX, Richard has supported medical device organizations of all sizes to understand the changes in worldwide device regulations and how they will affect their compliance gaps, and to plan for and implement their transition to changes in regulations.

Richard has developed a suite of proprietary tools that assist our clients in meeting worldwide regulatory compliance and successful product regulatory submissions.

John Love has 20+ years of experience in training and training development. His expertise includes both US and global regulatory standards, such as MDSAP, EU MDR, FDA QSR, and MDD (93/42/EEC).

William (Bill) Ditty has more than 2 decades of experience as a highly accomplished and results-oriented quality assurance executive, with extensive global expertise in strategy development and deployment, regulatory compliance, risk management, program and project management, and audits and inspections. Prior to working in the medical device industry, quality, and regulatory, Bill served as a commissioned officer in the US Coast Guard.

Bill has years of experience in FDA inspections, quality, and regulatory compliance, including creating a regulatory compliance program and implementing a mock FDA inspection program to proactively remediate issues prior to inspection. He has implemented global quality systems from the ground up (MDSAP, EU MDR, etc.), led transition and remediation projects, and has technical working knowledge of many medical device groups, including software and connected medical devices, orthopedic, neurology, ear / nose / throat, implantables, and radiology.

Chris has more than 30 years of experience in B2B marketing working for marketing agencies, consultancies and corporations alike. He has been actively involved in the medical device and IVD industry since 2004 and has personally written more than 200 articles on global regulatory and QMS compliance issues. He was previously Vice President of Marketing for a major medical device regulatory consultancy and subsequently served as an independent industry consultant from 2018-2023.

In his role with Oriel STAT A MATRIX, Chris oversees global corporate branding, marketing strategy, lead generation and metrics. Home base: Austin, Texas.

Throughout his 30+-year career, Ed Siurek has led quality and regulatory departments within the pharmaceutical and medical device industries for both US and international products. He has directed quality and productivity improvement on corporatewide projects in these sectors, spanning 6 continents and 55+ countries. His work has included organizational implementation and oversight of quality management systems, with both primary and direct responsibility for Regulatory Authority interactions. As part of Ed’s role, he has successfully worked with FDA to remediate FDA 483s, warning letters, and consent decrees. He has directed new facility startups and product launches both domestically and abroad. He has led programs and projects serving numerous functions, including medical device product development and launch, ISO 9000 and ISO 13485 certification, EU MDR, quality assurance and regulatory affairs management, Lean/Six Sigma implementation, and global project management leadership, among others.

Yogindra Dellow has two decades of experience in the life sciences field. She is well versed in medical device and pharmaceutical laws and regulations/standards, including FDA 21 CFR 820, 806, and 803; MDSAP; EU MDD/MDR; EU IVDD/IVDR; ISO 13485; and ISO 9001. Her expertise also includes quality management systems, auditing, CAPA, complaint handling, process validation, document control, supplier management, and postmarket surveillance activities.

For Oriel STAT A MATRIX, Yogindra has supported a wide range of medical device manufacturers to understand both the new EU Medical Device Regulation and the EU In Vitro Diagnostics Regulation. Yogindra has also played an integral role in developing the Oriel STAT A MATRIX IVDR training course.

Carolyn brings more than 30 years of quality system consulting, development, and management; quality system auditing; and quality engineering experience to each customer engagement.

Carolyn has worked with a wide range of medical device and pharmaceutical manufacturers to create, remediate, and optimize their QMS processes to meet the requirements of FDA regulations, EU MDR/IVDR, ISO 13485, ISO 9001, and other key international regulations and standards. In addition, Carolyn uses her expertise in quality systems training and auditing to help clients effectively implement their QMS processes, review them through internal audit programs, and present and defend them in inspections and audits.

Gene brings over 25 years of medical device, biotech, and high- tech sector experience and is responsible for software and quality management systems (QMS) projects at Oriel STAT A MATRIX.

His experiences span software development, risk management, quality systems, FDA/ISO regulations, qualification/validation, FDA/ISO auditing, CAPA, MDSAP, GCP, usability engineering, and the new EU IVDR and MDR.

Customers cite Gene’s ability to identify and resolve problems and to work effectively with personnel at all levels as key strengths.

Christine Park is a solution-focused and results-oriented professional with a wide array of experience spanning more than 30 years in regulatory affairs, quality systems, and business development. A former director of quality assurance, she has an MBA and a BS in medical technology. She brings a pragmatic and common-sense approach to help organizations design and establish good practices and achieve regulatory compliance.

Omar Gonzalez has over two decades of medical device and diagnostics RA/QA experience in the US, EU, Canada, Australia, Japan, Brazil, and China, working at companies such as Boston Scientific, Beckman Coulter, and Danaher, as well as serving as an auditor for SGS North America. His Notified Body and industry expertise includes serving as a Lead Auditor in auditing to FDA QSR, ISO 13485, MDSAP, and EU MDD/MDR/IVDD/IVDR, as well as assisting organizations to build quality management systems that are in full compliance with a variety of standards and regulations, including EU MDR (2017/745) and IVDR (2017/746). Omar also has extensive experience in supporting FDA inspections, 483/Warning Letter responses, and FDA remediation.

Alyssa has nearly two decades of experience in global quality and regulatory for life sciences. Her expertise includes establishing and managing globally compliant quality and compliance systems in a number of regulatory environments, auditing to a wide variety of regulations and standards, and successfully guiding regulatory submissions.

Joe Silvia has extensive experience in medical device software, device security (cybersecurity), mobile apps, wireless technology, wireless coexistence, interoperability, MDDS, and emerging technology; and with cybersecurity regulations and standards such as NIST Framework and FIPS. He is an expert in software development & validation and learning & development, and has worked in a variety of industries including molecular diagnostics (genomics). Joe combines technical and business acumen to coordinate system reviews and risk assessments with security, development, and operations teams. He is a collaborative and hands-on leader with excellent communication and interpersonal skills, building rapport with key stakeholders to deliver operational efficiency and compliance.

Joe has an intense focus on medical device safety, reliability, and protecting patient health information, utilizing his vast cybersecurity expertise to provide policy input on regulatory submissions from industry ? across the total product life cycle of networked, non-networked, and mobile medical devices ? to assess and evaluate potential threats and vulnerabilities, which could negatively impact the health of patients.

As a veteran of the US Army-Signal Corps, Joe received and completed training at the Fort Gordon Signal School/Cybersecurity Center of Excellence. He also holds an Executive MBA, a BSBA in Management Information Systems, and ITIL 4 Certification.

Harlow Thielke has more than 20 years of experience in the life sciences sector, with a focus on quality management systems. He has conducted audits to a wide array of standards and regulations, including ISO 13485, ISO 9001, 21 CFR 820, and more.

Jeff Kasoff has more than 30 years of experience in the medical device sector. His background includes quality system management, internal and supplier auditing, and training.

Lisa has 25+ years as a regulatory affairs professional and has experience in medical device sectors for tracheal intubation placement, vascular, cancer, ophthalmic, gynecologic, and general hospital indications. She has served as the vice-chair of the Atlanta Chapter of the Regulatory Affairs Professionals Society and has been a regular speaker and educator on regulatory affairs topics at Atlanta events, such as the Georgia Bio Life-Sciences Summit. Lisa has supported a wide range of medical device manufacturers to understand regulatory affairs submissions, compliance, and strategies for medical device product development, regulatory clearance, and postmarket activities for global markets.

Keshu Nso is a quality and regulatory affairs specialist with nearly a decade in the field. She is expert in providing strategic regulatory guidance and managing regulatory communications directed toward regulatory submissions for the biotech, pharmaceutical, and medical device industries.

DiCarlo Thompson has more than a decade of experience as a quality and regulatory affairs professional focused on regulatory remediation, quality control, and compliance. As an Oriel STAT A MATRIX consultant, DiCarlo is a technical documentation subject matter expert for EU MDR compliance across Class I to Class III medical devices. He has a bachelor’s degree in biology and prior experience as an R&D scientist.

Jon Marie Woolverton has more than 30 years of experience in the medical device sector. Her background includes product development, sterilization, RA/QA, and quality engineering, auditing, and management. Along with being skilled in Class II and Class III medical devices, she has developed and delivered training on medical device compliance, strategy, and global standards and guidances in a variety of settings.

Her specific areas of technical expertise include quality engineering; microbiology; biocompatibility; sterilization using ethylene oxide, steam, gamma, and ebeam modalities; packaging; clean-room environments; and laboratory environments such as wet chemistry and analytical instrumentation. Jon Marie also has experience with industry collaboration with medical equipment and intraocular lens manufacturing.