Ravali Reddy
Aspiring Clinical Operations & Regulatory Affairs Professional | MS Regulatory Affairs, Northeastern University | PharmD | Skilled in FDA 510(k), ISO 13485, Clinical Research & EDC Systems
- Role
- Regulatory Affairs Associate at KIMS Hospitals
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Ravali Reddy
I am an MS Regulatory Affairs graduate student at Northeastern University with a Doctor…
Experience
Regulatory Affairs Associate
Jan 2025 — Present · US
Author and compile FDA 510(k) and PMA submissions, ensuring compliance with 21 CFR Part 820 and EU MDR standards. • Implement CAPA processes, reducing non-conformance issues by 15% through proactive risk assessments and corrective actions. • Coordinate with R&D and quality teams to align product development with ISO 13485 and global regulatory requirements. • Streamline documentation workflows, cutting submission preparation time by 20% using eCTD and document control systems. • Monitor regulatory updates and provide strategic guidance to ensure compliance across medical device classifications. • Support clinical trial operations by managing eCRFs in EDC systems (Clindox, Medidata), achieving 98% data integrity.
Education
Northeastern University
Master's degree
2023 — 2025
Bharat Institute of Techonlogy
Doctor of Pharmacy - PharmD
2017 — 2023
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