Noblitt & Rueland provides specialized consulting services for our clients. We are in need of additional high quality consulting resources to handle demand or perform specialized tasks. Noblitt & Rueland requires the highest quality consultants that have a great deal of practical experience in the services they offer. If your background and experience match our requirements please forward your resume* to us by e-mail or mail.
 

*All correspondence will be kept confidential.

• Submissions- 510k, PMA, IDEs, De Novo, CE Mark
• Clinical Evaluation Reports (CERs)
• Auditors: FDA 21 CFR Part 820, ISO 13485, MDSAP, etc.
• Quality System Implementation & Auditing (FDA QSR/GMP, 13485)
• Ex-FDA: Mock Inspections, Warning Letter & FDA-483 remediation
• Design Control Implementation & Auditing
• Risk Management/hazard analysis/ISO 14971 Implementation & Auditing
• International/Global Country Specific Regulatory Compliance (please detail the countries; i.e. Japan, China, Brazil, etc)
• Software Quality Assurance
• Software Verification & Validation
• Software Development (describe languages and platforms, embedded processors & PCs)
• Hardware Design (digital & analog)
• Regulatory Affairs-Medical Device & Pharmaceutical Industry
• Proficiency in writing lifecycle procedures (SOPs)
• Multi-lingual experience on Regulatory Submissions & Quality Systems