Nikki Ibis
Director Regulatory Affairs at Boston Scientific
- Role
- Director of Regulatory Affairs at Boston Scientific
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
About Nikki Ibis
Goal-oriented Regulatory Specialist with 15 years of experience in the medical device industry and eight years in the Regulatory profession. Experience in managing multiple projects with tight deadlines and participating in cross-functional teams. Strengths include attention to detail, problem solving skills and adapting to change. Currently the Interventional Cardiology Regulatory lead for MDR activities in Boston Scientific.
Experience
Director of Regulatory Affairs
Apr 2025 — Present
Education
University of Minnesota
Bachelor of Science (B.S.), Neuroscience
Argosy University
Associate of Arts and Sciences (A.A.S.), Histotechnology
Skills
- Laboratory
- Glp
- Histology
- Iso 13485
- Quality Assurance
- Enthusiasm to Learn
- Pma
- Medical Devices
- Capa
- Quality System
- Microsoft Office
- Continuous Improvement
- Cross-Functional Team Leadership
- Iso 14971
- Histopathology
- Sop
- Fda
- Lean Principles
- Work Independently with Minimal Supervision
- Adaptable to Changes
- Management
- Validation
- Close Attention to Detail
- Regulatory Affairs
- Ms Project
- Regulatory Submissions
- Staining
- 21 Cfr Part 11
- Fda Gmp
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