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About Us

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Our People

An experienced consulting team averaging 20+ years of life sciences industry experience

Regulatory compliance continues to become more complex. Having worked with thousands of companies, we have certainly seen the negative consequences of hiring inexperienced people. That’s why we emphasize quality over quantity in everything we do. In practical terms, that means we hire only highly experienced quality and regulatory professionals. As a general rule, our specialists have spent on average 20 years working “in the trenches” for medical device companies before sharing their knowledge with our clients as consultants and trainers. The Oriel STAT A MATRIX team has particularly deep expertise in the following areas:

  • European Medical Device Regulation (2017/745)
  • European In Vitro Diagnostic Regulation (2017/746)
  • Medical Device Single Audit Program (MDSAP)
  • US FDA 21 CFR Part 820 and ISO 13485:2016 compliance
  • Quality management system auditing
  • CE Marking and FDA 510(k) submissions
  • Clinical evaluation and risk management
  • Postmarket surveillance and complaint handling
  • Training on all topics noted above

Our consultants and trainers provide our customers with practical interpretations of US, European, and global requirements along with the knowledge and skills to help develop, implement, and maintain business-centric quality and regulatory compliance solutions that are consistent with your corporate culture and strategic goals. They are ready to help your organization start a new program, expand an existing program, or reenergize a stalled initiative.

Key members of our leadership team

Our highly experienced leadership team supports the needs of our clients and our highly vetted international network of 100+ consultants worldwide. All of our global consultants are fluent in English and many also speak German, French, Spanish, Portuguese, Chinese, or Korean. Regardless of where you are located, we are ready to assist.
 

  • Judith Glaser

    Judith Glaser - Chairwoman

    Judi has served as Chairwomen of Oriel STAT A MATRIX since 2009. Her responsibilities include overseeing the financial operations of the organization, developing new products, analyzing market opportunities, and managing consultant operations. She also designs and manages the implementation of internal processes and tools that support Oriel STAT A MATRIX’s client services. Judi is a majority shareholder of the company. 

    Prior to joining Oriel STAT A MATRIX, Judi was an Executive Director at Morgan Stanley where her responsibilities included equity and commodity structured product development from origination to implementation, integrating communication platforms, strategic planning and analysis, and project management.

  • Alan Marash

    Alan Marash - CEO

    Alan focuses on strategic planning and managing Oriel STAT A MATRIX’s key client relationships, partnerships, and global deployments. Alan is committed to maintaining the company’s heritage of driving performance improvement, with the goal of helping customers reach the highest levels of success and profitability.

  • Chad Hedlund

    Chad Hedlund - EVP, Life Sciences Consulting and Education

    Chad provides the overall strategic leadership for Oriel STAT A MATRIX’s Life Sciences Consulting and Education services. His focus is on guiding our customers to a successful market entry of their product (e.g., medical device, IVD, or combination product) while also building and optimizing our customers’ quality and regulatory compliance functions in a manner that balances shareholder, customer, global regulatory, and employee needs.

    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

    Kate Leith - Sr. VP, Life Sciences Consulting and Education

    Kate is responsible for ensuring that Oriel STAT A MATRIX’s Body of Knowledge is up to date with rapidly changing regulatory requirements and includes the tools and topics our customers need in order to stay competitive in a quickly evolving industry landscape.

    Kate brings over 25 years of experience in global quality, compliance, and learning and development in the life sciences sector to Oriel STAT A MATRIX.  Her expertise spans the total product life cycle, including design development, premarket quality, operations and supplier quality, and postmarket surveillance. Strategic accounts value Kate’s keen understanding of competency models and seek her assistance to develop scalable training programs that address their training needs in all facets of quality/regulatory, problem-solving, and technical topics.  Kate’s deep knowledge of regulatory and quality topics – coupled with her keen understanding of developing user-friendly and relevant training content – ensures that Oriel STAT A MATRIX’s training library is the best in the industry.

  • Richard Vincins

    Richard Vincins - VP, Regulatory Affairs

    Richard is based in the UK and leads global regulatory affairs projects for our international customer base. He also ensures that Oriel STAT A MATRIX and our affiliates are well positioned to support global customers through the EU Medical Device Regulation and In-Vitro Diagnostic Regulation transitions. Richard brings over 25 years of global medical device, IVD, and pharmaceutical QSR experience to each customer engagement, employing his extensive expertise in submission content, regulatory classifications, risk management, software-driven products, postmarket surveillance, complaint handling, adverse event reporting, inspection readiness, and auditing.

    Richard is responsible for over 30 FDA 510(k) clearances across 10 different branches. He has been involved in EC certification for 62 technical files covering 30 different project types, varying from Class I through III.   

    Richard holds a BS degree in Biomedical Biology. He is a voting member of ISO US Technical Advisory Groups (TAG) 176 for Quality Management Systems (ISO 9001) and 302 for Auditing Management Systems (ISO 19011).

  • Alicia Hemphill

    Alicia Hemphill - VP, Regulatory Affairs

    Alicia provides technical oversight for Oriel STAT A MATRIX’s regulatory affairs practice, focusing on the firm’s US-based customers.

    Alicia’s regulatory experience spans over two decades in negotiating and bringing medical devices from concept through to commercialization. She is responsible for two IDEs, two PMAs, nine original 510(k)s, more than twenty-plus direct FDA and NB Q-Sub negotiations, five design dossiers, and multiple approvals in Canada, China, Japan, Latin America, and Australia. In her most recent role before joining Oriel STAT A MATRIX, Alicia led the EU MDR gap assessment activities within her organization, successfully placing the company on the path to compliance.

    Oriel STAT A MATRIX’s customers cite Alicia’s ability to identify, develop, and solve complex regulatory and organizational challenges as the key to their successful outcomes.

    Alicia holds an MS in Engineering Technology.
     

  • John Love

    John Love - Sr. Director, Learning and Education

    John has over 20 years of training and course development experience that spans production management, quality and regulatory training, document control, root cause investigation, and internal auditing. His diverse background equips him with practical knowledge that enhances the classroom training experience. John is passionate about developing and delivering training at a high level to ensure not only that learning objectives are met during classroom time, but also that lessons learned are maintained and applied back to the job.

  • Alyssa Schwartz

    Alyssa Schwartz - Director, Quality and Regulatory Consulting

    Alyssa has nearly 20 years of medical device and IVD experience spanning the entire product life cycle for global submissions, product launch, operations, auditing, quality system development, managing global inspections, and remediation. She has facilitated FDA Warning Letter and 483 mitigation and has experience with USFDA, CMDCAS, ANVISA and EU Competent Authorities. 

    Alyssa leverages her extensive background and real-world experiences to ensure that customers obtain both a transparent audit evaluation and consultative engagement.  Because of Alyssa’s involvement with a broad range of product designs and QMS processes, she is quickly able to use a relevant real-world example to support customer success.

    Alyssa holds a MS in Bioscience Regulatory Affairs from John Hopkins University and a BS in Microbiology from the University of Pittsburgh.

  • Carolyn Tomlinson

    Carolyn Tomlinson - Director, QMS Training

    Carolyn oversees our auditor courses and manages the firms relationship with Exemplar Global, the accreditation body for these courses. Carolyn brings more than 20 years of quality system development and management, quality system auditing, and quality engineering experience to the classroom. Her work experience has been in various industries, including medical device and pharmaceutical products, nonwoven materials, electronics, publishing, and polymer rigid film production. Carolyn leverages her diverse background and real-world experiences to ensure that students obtain a practical understanding of classroom topics. Students consistently comment that Carolyn’s involvement with a broad range of manufacturing technologies helps to personalize and enhance their learning experience.  

    Carolyn holds a BS from Virginia Tech in Chemical Engineering with a minor in Chemistry. She is a certified Six Sigma Black Belt.

  • Gene Redig

    Gene Redig - Director, Quality and Regulatory Consulting

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

    Gene is a results-driven and people-oriented professional with a proven track record in quality management, regulatory affairs, cross-functional project management, and business operations. He excels at driving leading-edge technology-based solutions from both internal and external points of view. He has hands-on experience with 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.

    Gene holds a BS for Computer Science and an MBA. He has ASQ certifications as a Certified Quality Manager (CQM), Certified Software Quality Engineer (CSQE), and Certified Quality Auditor (CQA).

  • Ed Siurek

    Ed Siurek - Director, Quality Consulting

    Ed leads quality system design and development projects for Oriel STAT A MATRIX. He also oversees all audit services for our customers, including mock MDSAP audits, supplier audits, and baseline and preassessment 13485/9001/QSR audits. Ed has more than 20 years of experience in practical, hands-on application of quality standards, process and continuous improvement, facility and supplier audits, and regulatory compliance in both the pharmaceutical and medical device industries. Ed has supported life sciences organizations on 6 continents and in more than 55 countries, giving him a unique perspective that allows him to easily perform and succeed in diverse environments.

    Ed holds an MS in Information Systems Management from the Keller School of Management in Cleveland, with a concentration in Project Management. He also earned a BS from Purdue University in West Lafayette, IN. He is a certified Six Sigma Black Belt.

  • Omar Gonzalez

    Omar Gonzalez - Director, Quality Auditing and Consulting

    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). Omar also has extensive experience in supporting FDA inspections, 483/Warning Letter responses, and FDA remediation.

  • Yogindra Dellow

    Yogindra Dellow - Director, Quality and Regulatory Consulting

    Yogindra has two decades of experience in the life sciences field. She is well versed in medical device and pharmaceutical laws and regulations/standards. She has served as a Response Team Lead for FDA and Notified Body remediation activities regarding EU MDR or vigilance trends, Medwatch inquiries, FDA 483s, and recall reports.

    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.  Customers value her direct approach and expansive knowledge of the regulations.

  • Gina Abudi

    Gina Abudi - VP, Program Management

    Gina provides project management guidance and direction for our complex engagements. She has more than 25 years of experience in project management and has served a wide array of industries.

     

  • Ernani Pires

    Ernani Pires - VP, Performance Excellence

    Ernani facilitates quality and productivity improvements using fact-based decision making to achieve key organizational objectives. He draws on more than 40 years of experience in quality management systems and performance improvement methodologies.

    Before joining Oriel STAT A MATRIX, Ernani was the first US President of SGS ICS – one of the largest Certification Bodies in the world.

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