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Our People

An experienced consulting team averaging 25+ 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 25 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)
  • 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.
 


Key members of our team:

  • 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 - Sr. VP, 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 nearly two decades and includes quality, regulatory compliance, technical, and leadership roles at companies such as Medtronic, Boston Scientific, and Guidant.

  • Kate Leith

    Kate Leith - VP, Training 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.

  • Ed Siurek

    Ed Siurek - VP, 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 Green Belt and Black Belt.

  • 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).

  • Lori Kahler

    Lori Kahler - VP, Regulatory Affairs

    Lori is responsible for overseeing regulatory affairs services for our US customer base. Lori has 25 years of domestic and international experience in RA/QA, with a broad multifunctional background in regulatory, clinical, and quality assurance. Lori has supported numerous organizations in gaining global market entry and achieving advanced product performance. She has extensive experience interacting with FDA, the European Medicines Agency and regulatory authorities of individual EU Member States, the Australian TGA, the Japanese Pharmaceuticals and Medical Devices Agency, China’s FDA, Korea’s FDA, Health Canada, ANVISA in Brazil, and other regulatory authorities around the world. 

  • Carolyn Tomlinson

    Carolyn Tomlinson - Director, Quality Systems 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.

  • 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.

  • Gina Abudi

    Gina Abudi - Vice President, 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.

     

Our team is here to help. Call 1.888.532.6360 or contact us online ›