Tanya Eberle
Sr. Vice President of Regulatory Affairs at Irrimax Corporation
- Role
- Sr Vice President at Irrimax Corporation
- Location
- Roswell, GA, US
- LinkedIn followers
- 500 followers
About Tanya Eberle
A strategic Regulatory professional in the medical device industry. Focused on building value in small/start-up environments. Proven success in designing regulatory strategies, product development, pre-clinical and clinical testing, negotiations with Regulatory bodies, manufacturing start-up, commercial launch, and post-market requirements for domestic and international markets. Strong industry knowledge and leadership resulting in the achivement of corporate and M&A goals. Commercialization experience in US (Original Panel Track PMA, PMA Supplements, 510(k)s, IDE, HDE), EU via MDR, Canada, Australia, and Latin America. Experience Highlights:• Acquisition of wound irrigation company by Archimed - 2024• Acquisition of orthopaedic start-up by Wright Medical - 2018• Original PMA Approval for Novel Synthetic Cartilage - 2017• IDEs for Orthopaedic and Cardiovascular devices• 510ks for Instrumentation, Infusion Pump & Combination Devices• Down-classification for Companion Devices • EU MDR for Class IIb, IIa, and Class 1 devices
Experience
Sr Vice President
Feb 2026 — Present
Education
Kennesaw State University
BS, Biology
Skills
- Pma
- Biotechnology
- Ce Marking
- Clinical Trials
- Design Control
- Fda
- Quality System
- Product Development
- Regulatory Affairs
- Orthopedic
- Regulatory Submissions
- Medical Devices
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