Sammie Joseph-Fredericks
MS in Regulatory Affairs | Certified QMS Lead Auditor (ISO 13485:2016) | Navigating Regulatory with Precision & Purpose
- Role
- Regulatory Affairs Manager at Endologix LLC
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
About Sammie Joseph-Fredericks
Strategic. Adaptable. Rooted in Regulatory Excellence.With over a decade in regulatory affairs, I’ve built a career around bridging global compliance requirements with smart, forward-thinking regulatory strategy. From Class II to Class devices, I’ve supported product development, international registrations, audits, and change control, helping teams bring innovative technologies to market with clarity and confidence.My experience spans large, global organizations, mid-sized companies, and smaller mission-driven teams, giving me a well-rounded view of what regulatory success looks like in different environments. I’m comfortable navigating complexity, translating requirements into action, and collaborating across functions to move things forward.I’m committed to ensuring regulatory strategy serves as a catalyst for innovation and growth and not a roadblock.
Experience
Regulatory Affairs Manager
Sep 2023 — Present · US
Education
St. Cloud State University
Master of Science (MS), Regulatory Affairs and Sciences
Skills
- Validation
- Sap
- Regulatory Requirements
- U.s. Food and Drug Administration (Fda)
- Regulatory Affairs
- Sop
- Fda
- Auditing
- Cross-Functional Team Leadership
- Quality System
- Software Documentation
- Medical Devices
- Management
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