Regulatory Affairs Clinical Specialist
1 week ago
Salary: $46,000 - $47,500 per year
Language Requirement: Spanish (Required)
Position SummaryThis 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.
- 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 TypeFull-time
Benefits- Paid time off
- 2 years
- Monday to Friday
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