Team
Rob Schulz, RAC
President and COO
Rob has over 18 years of multifunctional FDA regulatory experience with 16 years of Management experience and 12 years of Global Quality and Regulatory Affairs experience. Rob has hands on experience in Quality and Regulatory compliance for Class I, II, and III, devices including combination, IVD/companion Diagnostics, sterile, software, and implantable products for both design and manufacturing. As a thought leader, Rob has leveraged his vast project management, leadership and combination product experience to build effective teams, drive and deliver projects on time and trouble shoot challenges to execute projects.
Academic & Professional Qualifications:
- BS, Biology, California State University, Chico
- Graduate Coursework in Regulatory Science / Quality Systems / Device Regulations, University of Southern California
Training, Quality Systems, & Specialties:
- Regulatory Affairs/Submissions/Strategy
- Quality System Management
- ISO 13485, including completion of audit training
- ISO 14971
- IEC 60601
- ISO 10993
- IEC 62366
- IEC 62304
