Regulatory Affairs Clinical Specialist

1 week ago


Fort Lauderdale, Florida, United States D&H National Research Center Full time
Job Overview

Salary: $46,000 - $47,500 per year

Language Requirement: Spanish (Required)

Position Summary

This full-time on-site position at D&H National Research Centers involves a pivotal role for a Regulatory Specialist. The primary responsibility includes ensuring adherence to regulatory standards and staying informed about evolving regulatory guidelines.

Key Responsibilities
  • Conduct thorough research and analysis to guarantee compliance with regulatory standards.
  • Oversee compliance initiatives, including the formulation and execution of policies and procedures.
  • Prepare and manage the complete process of regulatory document submissions to the Institutional Review Board (IRB), from initiation to conclusion.
  • Review documentation for precision and thoroughness.
  • Maintain data management systems to monitor and report on regulatory activities.
  • Collaborate with cross-functional teams to ensure adherence to regulatory standards.
  • Stay updated on regulatory changes and communicate relevant updates to stakeholders.
Qualifications
  • Medical experience in a related field (e.g., healthcare, life sciences).
  • Experience in regulatory affairs or a similar domain.
  • Understanding of Good Clinical Practice (GCP) guidelines and regulations.
  • Familiarity with clinical laboratory operations and medical terminology.
  • Proficiency in statistical software for data analysis.
  • Exceptional attention to detail and analytical capabilities.
  • Strong communication and interpersonal skills.
  • Fluency in Spanish.

Note: This job description provides a general overview of the position and is not an exhaustive list of all responsibilities, duties, and skills required.

Job Type

Full-time

Benefits
  • Paid time off
Experience Level
  • 2 years
Schedule
  • Monday to Friday


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