Senior Regulatory Affairs Consultant

16 hours ago


Mumbai, Maharashtra, India Vision Achievement Full time
Job Overview

We are seeking an experienced Senior Regulatory Affairs Consultant to join our team at Vision Achievement. This role involves providing expert consulting services in the RA/QA domains, specifically focusing on medical devices, in vitro diagnostics, lab-developed tests, pharmaceuticals, and cosmetics.

Key Responsibilities
  • Consulting & Auditing: Provide expert guidance on regulatory and quality assurance infrastructure, ensuring compliance with relevant regulations and standards.
  • Investigation of OOS/OOT Results: Conduct thorough investigations of Out of Specification (OOS) and Out of Trend (OOT) results, considering potential errors in calculation, method/procedure, instrumentation, and sampling.
  • Compliance: Ensure adherence to relevant 21 CFR sections.
Requirements
  • Educational Background: Bachelor's degree in Engineering, Science, or a related Life Sciences field.
  • Leadership Experience: Demonstrated progression in responsibilities, such as leading regulatory submissions.
  • Industry Experience: Significant RA/QA experience in medical devices, in vitro diagnostics, pharmaceuticals, or cosmetics.
Compensation

The estimated annual salary for this role is $120,000 - $180,000, depending on qualifications and experience.



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