Jeff Nikutin
Sr. Program Manager at ICU Medical
- Role
- Program Manager at ICU Medical
- Location
- Lake Forest, IL, US
- LinkedIn followers
- 500 followers
About Jeff Nikutin
Experienced Program Manager with a demonstrated history of working in the medical device industry. Skilled in Verification and Validation (V&V), Design Controls, Device Labeling requirements, International registrations and Change Control. Strong healthcare services professional with a Bachelor\'s degree focused in Business/Commerce, General from University of Wisconsin-Parkside.
Experience
Program Manager
Feb 2017 — Present · Lake Forest, IL, US
Education
University of Wisconsin-Parkside
Bachelor's degree, Business/Commerce, General
1993 — 1996
Skills
- Product Development
- Technology Transfer
- Regulatory Submissions
- Gcp
- Biopharmaceuticals
- Biotechnology
- Quality Management
- Regulatory Affairs
- Iso 13485
- Regulatory Requirements
- Iso
- Pharmaceutical Industry
- Sop
- Fda
- Glp
- Validation
- 21 Cfr Part 11
- Quality System
- V&V
- Design Control
- Software Documentation
- Root Cause Analysis
- Computer System Validation
- Pharmaceutics
- Gxp
- Quality Auditing
- Cross-Functional Team Leadership
- Iso 14971
- Quality Assurance
- Medical Devices
- Capa
- Quality Control
- Change Control
- Gmp
- R&D
- Lims
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