Jorge Montoya
- Role
- Senior Director, Medical Device Combination Product Development at Tolmar
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Jorge Montoya
Medical Device leader with 23 years of experience and a successful track record of…
Experience
Senior Director, Medical Device Combination Product Development
Apr 2022 — Present · New York, NY, US
Lead the device organization at Tolmar Pharmaceuticals. Work along side Formulation development, Analytical Development, Commercial, Clinical Development and TA KOLs to define the user needs and develop the device strategy for the combination product and drug delivery system. Lead development of Combination Product programs and support Life Cycle Management work stream. Development of device constituents as part of combination products by levering drug cGMP-based streamlined approach (also knows as 21 CFR Part 4) and incorporating the QMS device elements in particular Design Controls (21 CFR 820.30).
Education
Rensselaer Polytechnic Institute
BS, Biomedical Engineering
1993 — 1998
Wichita High School, East
High School Diploma and International Baccalaurate (IB) Diploma, International Baccalaurate Programme - high school, High School
1989 — 1993
Columbia Business School
Certification - Executive Education, Management and Leadership
2020 — 2020
Politecnico Nacional del Santa, Chimbote, Peru
Secondary School, Electrical Systems
1987 — 1989
Wichita State University / Via-Christi Orthopedic Research Institute
MS, Mechanical Engineering - Orthopedic Product Development
1998 — 2000
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