Meet the Team And Careers
Glen is the senior partner, and is the CRO Group’s clinical investigation, biotechnology and IVD product, and software/Part 11 expert. He has over 25 years of experience in health care. He has brought several complex Class II and III medical instruments and systems from drawing board to production for Millipore Corporation during his 9 years with the company. During this time, he specialized in international and software regulatory engineering for several Millipore divisions. Prior to joining the CRO Group, Glen was the Director of the USA operation for TUV Product Service, Medical Division, responsible for implementation of ISO 9001, ISO 13485, and EU MDD/IVDD/CE Marking certifications for over 200 medical device manufacturers. Glen has a M.Eng in Biomedical Engineering, and a BSEE.
Mark is the CRO Group’s implantable and invasive biocompatibility, packaging, and sterilization expert. Mark is the principal of Roberts Consulting and Engineering. He is a certified lead auditor and CE marking and product sterilization expert. He has over 20 years of medical device industry experience. Previously he was the head of western US operations for TUV Product Service. Prior to that he was Manager of Quality System for Becton Dickinson and Sterility Assurance Manager for Baxter Healthcare, Bentley Division
Ira Duesler, Jr.
Ira is a CRO Group active and inactive medical device and quality system compliance and regulatory expert. Ira has over 20 years experience in this field, preparing 510(k) submissions and international product registrations as well as managing and directing quality systems.
Dwight is a CRO Group medical device software/SaMD/SaaS regulatory expert. Dwight supports preparation and presubmission review of software documentation for 510(k) submissions and international product registrations. He also supports QMS projects involving software/computerized system validations.
Leo is the CRO Group’s active (electrical safety and EMC) medical device and quality system compliance expert. Leonard is the principal of Eisner Safety Consultants. He is a licensed professional engineer in safety engineering. He has 15 years experience in product safety at UL, TUV and Karl Storz. Leonard was the Manager of Compliance Engineering at Karl Storz and Senior Product Safety engineer at TUV Product Service.
Bill is a CRO Group medical device and quality system compliance and regulatory expert. Bill has over 15 years experience in this field, preparing 510(k) submissions and international product registrations and has brought dozens of medical device manufacturers through the ISO 13485, CE Mark, and CMDCAS certification process..
Shuzhi is a CRO Group regulatory associate. Shuzhi has a B.S. Nursing and a M.S. Regulatory Affairs. She is fluent in Cantonese, English, and Mandarin and joins us from the Shenzhen region of China. Shuzhi supports CRO Group’s clinical study and medical device approval projects.
Careers at CRO GroupIf you’re ready to join our team working with some of the leading as well as startup companies focused on tomorrow’s products in the aesthetic beauty, diagnostic, mobile medical apps, robotics, and wearables, we want to hear from you. The CRO Group offers a dynamic work environment and provides competitive compensation, benefits, and performance-based incentives.
We are looking for students in a B.S.E.E. at the junior or senior level, or M.S. in Regulatory Affairs with the Knowledge, Skills, and Abilities below:
- Support CRO Group consultants working with our clients in upgrading their Quality Management Systems to ISO 13485:2016 compliance as well as towards MDSAP.
- Support CRO Group consultants working with our clients in preparing for IEC 60601-1 test compliance for their electronic medical device products for both FDA 510(k) premarket submissions as well as international registrations.
- Support CRO Group consultants working with our clients in preparing for IEC 62304 compliance for their medical device software, SaMD, and SaaS for both FDA 510(k) premarket submissions as well as international registrations.
KNOWLEDGE, SKILLS AND ABILITIES
- Basic working knowledge of medical device quality systems, electromedical and software life cycle standards
- Able to review regulations/guidances/standards requirements and apply to projects.
- Maintain project info and data including project plans, agendas, minutes, action lists, etc.
- Able to develop basic procedures and document processes
- Proficient with MS Word, Excel, and PowerPoint.
- Able to read and understand technical material.
- Able to communicate across all levels of the organization, work effectively with multiple cultures,
- Works in an organized manner, with attention to detail, and maintains a professional demeanor
- Works in a responsible manner, from filling out timesheets and expense reports accurately on time, to respecting client project deadlines, and everything in between
- Our client’s offices/facilities as well as home office
- Up to 50% travel may be required