Poornima Pattabi
Shelton,CT
Summary
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
5
5
years of professional experience
Work History
Regulatory Affairs Labelling Specialist
DePuy Synthes, Johnson & Johnson
05.2022 - Current
- Followed all company policies and procedures to deliver quality work.
- Listened and responded to customer requests and forwarded necessary information to superiors.
- Maintained current understanding of market conditions, compliance standards and best practices.
- Lead E2E labeling change request review, Off shore co-ordination for Labeling Updates and approve Labels in PLM for Production release.
- Interpreted clients' needs and introduced services to fit specific requirements.
- Maintained database systems to track and analyze operational data.
- Planning and Tracking various Projects in QB, Working with cross functional teams to ensure on-time Project deliverables.
- Update weekly project reports to senior management.
- Prioritized project-related tasks to efficiently complete essential tasks
Regulatory Affairs Associate
Abphina LLCWhit Plains, NY
01.2019 - 05.2020
- Managed and Prepared documents for submitting 510k, PMA for New Product.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Prepared and maintained document inventory for core dossier preparation.
Education
Master of Philosophy - Physics
Bharathidasan University
Thiruchirappalli12.2007
Bachelor's of Education - Teachers Education
Thiruvalluvar University
Vellore11.2006
Master of Science - Physics
University of Madras
Chennai11.2004
Bachelor of Science - Physics
University of Madras
Chennai04.2002
Skills
- TRAINED IN FPX (PM)
- SOFTWARE SKILLS: Windchill, Adaptiv, Loftware, Enlabel and WWL
- Regulatory Expertise : FDA, EUMDR, ISO 13485, ISO 15223 - 1 UKCA, UDI
Timeline
Regulatory Affairs Labelling Specialist
DePuy Synthes, Johnson & Johnson
05.2022 - Current
Regulatory Affairs Associate
Abphina LLCWhit Plains, NY
01.2019 - 05.2020
Master of Philosophy - Physics
Bharathidasan University
Bachelor's of Education - Teachers Education
Thiruvalluvar University
Master of Science - Physics
University of Madras
Bachelor of Science - Physics
University of Madras
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