Senior Regulatory Affairs Specialist @ (February 2024 - July 2024)
Regulatory Specialist III @ (February 2022 - March 2024)
Regulatory Specialist II @ (February 2022 - October 2022)
Regulatory Affairs Associate @ (July 2020 - February 2022)
Quality and Regulatory Associate @ RAC Medical Device (April 2020 - July 2020)
Regulatory consultant @ (January 2020 - April 2020)
Regulatory Affairs Associate @ (April 2019 - September 2019)
Simran P Education
Northeastern University
Simran P Skills
Part 820
Regulatory Approvals
PSUR
PMCF
510(k)
Pre Submission
Communication
ISO 13485, ISO 14971, ISO 10993 ·
EU MDR MDD
Regulatory Strategy Development
Regulatory Operations
Regulatory Policy
Product Registration
Regulatory Affairs
QSR
Pharmaceutical Industry
Clinical Trials
Medical Devices
Regulatory Submissions
Quality Assurance
Auditing
Good Clinical Practice (GCP)
Analytical Skills
Standard Operating Procedure (SOP)
Clinical Development
Good Laboratory Practice (GLP)
Project Management
510K
Excellent writing skills
Corrective and Preventive Action (CAPA)
ISO 13485
Microsoft Excel
Microsoft Office
Microsoft PowerPoint
Microsoft Word
Management
Leadership
Public Speaking
Teamwork
Excellent communication
Regulatory Analysis
Regulatory Documentation
Global Regulatory Compliance
Regulatory Guidelines
Regulatory Intelligence
21 CFR
Premarket Approval (PMA)
ISO 13485, ISO 14971, ISO 10993
IEC 60601, IEC 62304, IEC 62366
Simran P Summary
Simran P, based in United States, is currently a Senior Regulatory Affairs Specialist at React Health. Simran P brings experience from previous roles at ResearchDx and CurveBeam. Simran P holds a Northeastern University. With a robust skill set that includes Part 820, Regulatory Approvals, PSUR, PMCF, 510(k) and more. Simran P has 1 emails on RocketReach.
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