FDA Attorney | Remote

Crossing Hurdles; EE. UU.; A distancia; USD 193.000 - 551.000; A tiempo parcial

Descripción de la vacante

Crossing Hurdles is seeking an experienced FDA & Regulatory Compliance Attorney for a remote contract position. The role involves analyzing FDA statutes, regulations, and guidance, reviewing regulatory submissions, and assessing regulatory risk to guide client decisions.

The ideal candidate holds a JD with an active USA license, excellent legal research and writing skills, and the ability to convey complex regulatory concepts to diverse audiences.

Formación

• Experience with FDA regulatory analysis and compliance documentation.
• Strong legal research skills with attention to detail.
• Verbal communication skills for conveying complex concepts.

Responsabilidades

• Analyze and interpret FDA statutes, regulations, and guidance documents.
• Review and critique regulatory submissions and compliance documentation.
• Assess scenarios for regulatory risk and enforcement trends.
• Draft or edit scenario-based questions and answers for regulatory practices.
• Identify emerging issues in FDA compliance and recommend solutions.
• Generate clear explanations of complex legal requirements for audiences.
• Contribute feedback on project deliverables for content accuracy.

Conocimientos

FDA regulations

Legal research

Legal writing

Regulatory risk assessment

Verbal communication

Educación

Juris Doctor (JD)

Descripción del empleo

Position: FDA & Regulatory Compliance Attorney

Type: Contract

Compensation: $140 - $400/hour

Location: Remote

Commitment: 10 40 hours/week

Role Responsibilities

• Analyze and interpret FDA statutes, regulations, and guidance documents


• Review and critique regulatory submissions and compliance documentation


• Assess scenarios for regulatory risk and enforcement trends


• Draft or edit scenario-based questions and answers for regulatory practices


• Identify emerging issues in FDA compliance and recommend solutions


• Generate clear explanations of complex legal requirements for audiences


• Contribute feedback on project deliverables for content accuracy

Requirements

• Experience with FDA regulatory analysis and compliance documentation


• Strong legal research skills with attention to detail


• Verbal communication skills for conveying complex concepts


• Life sciences industry knowledge and regulatory submissions experience


• Ability to assess regulatory risk and enforcement trends


• Proven experience in legal writing and issue resolution


• Juris Doctor (JD) and active license to practice in the USA