Profile
| Username | Felicia.Hosey |
| First Name | Felicia |
| Last Name | Hosey, RAC |
| Title | Certified Regulatory Leader | MedTech & IVD | Global Regulatory Affairs |
| Location | Caldwell, WV |
| Professional Bio/Service Description | I am a certified regulatory professional with over 21 years experience in the medical device industry, specializing in medical device (MD) and in vitro diagnostic (IVD) products. My core competencies include research and development, clinical testing, U.S. Food and Drug Administration (FDA) regulations, global regulatory affairs, corrective and preventive action (CAPA), EU Medical Device Regulation (MDR), EU In Vitro Diagnostics Regulation (IVDR), consulting, quality management systems (QMS) and risk management. I have a proven track record of successfully navigating complex and dynamic global regulatory environments, ensuring compliance and quality standards, and facilitating product development and approval processes in various markets. |
| Your Website | |
| LinkedIn URL | |
| Languages | English |
Expertise
| Years of MedTech Experience | 21 |
| Licenses and Certifications | RAC – Global |
| Areas of Expertise | Regulatory Affairs, Diagnostic Development, Molecular Diagnostics, Product Development, Compliance & Auditing |
| Regions of Expertise | United States (US), European Union (EU), Canada, United Kingdom (UK), Australia |
| Hourly Rate (Range) | Contact for Details |
| Service Provided | Consulting |