Zuren Shethwala
- Role
- Senior Regulatory Affairs Specialist at Nuvasive
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
About Zuren Shethwala
M.S. Biomedical Engineering/Pharmaceutical Sciences; B.S. Biology
Experience
Senior Regulatory Affairs Specialist
Feb 2022 — Present
Coordinate and prepare document packages for regulatory submissions for new and mature products within the Global Implant Systems (GIS) portfolio, ensuring compliance with local and regional registration requirements. • Execute timely regulatory strategies to meet company goals and maximized efficiencies. • Compile all materials required for STED submissions, license renewal and annual registrations. • Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. • Keep abreast of regulatory procedures and changes. Recommend strategies for earliest possible approvals of clinical trials applications. • Determine the appropriate regulatory strategy for new and existing Global Implant Systems (GIS) products and document all related activities to remain in compliance. • Demonstrate global regulatory expertise in product submissions and evaluate changes with local regulations. • Collaborate with various departments to review the required plans, procedures, and regulatory decisions for new or existing products. • Review regulatory requirements from other departments for new product designs or changes to existing designs. • Review technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry. • Prepare and maintain regulatory pre-market submissions and other pre-market filings to assist in acquiring appropriate commercial distribution clearances. • Support product import by providing applicable regulatory documentation and certificates.
Skills
- Team Leadership
- Team Management
- Research
- Time Management
- Anatomy
- Microsoft Excel
- Healthcare
- Oracle Applications
- Strategic Planning
- Event Planning
- Medical Terminology
- Direct Patient Care
- Microsoft Sql Server
- Teamwork
- Sales
- Dentistry
- Public Speaking
- Sterilization
- Project Management
- Powerpoint
- Leadership
- Customer Service
- Oracle Database
- Human Anatomy
- Social Media
- Science
- Spanish
- Data Analysis
- Problem Solving
- Laboratory
- Management
- Clinical Research
- Microsoft Office
- Microsoft Word
- Sql*Plus
- Biology
- Oracle Sql Developer
- Cell Culture
- Critical Thinking
- Bacterial Culture
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