Katelynn Mains
Regulatory Affairs
- Role
- Director Regulatory Strategy Devices at Bayer
- Location
- Pittsburgh, PA, US
- LinkedIn followers
- 500 followers
Experience
Director Regulatory Strategy Devices
Oct 2024 — Present · Pittsburgh, PA, US
Education
University of Pittsburgh
Bachelor of Science, Bioengineering
2005 — 2009
Plum Senior High School
High School Diploma
2001 — 2005
Skills
- Positive Team Player
- Interpersonal Communication Abilities
- Motivation
- Positive Energy
- Fda Gmp
- Class Iii Medical Devices
- Regulatory Affairs
- Regulatory Submissions
- Regulatory Requirements
- Quality System Compliance
- International Regulations
- Quality Auditing
- Iso 13485
- Complaint Investigations
- Trend Analysis
- Gap Analysis
- Change Orders
- Premarket Approval
- Interdepartmental Relations
- Medical Devices
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