Remote FDA Toxicology Subject Matter Expert

Tunnell Government Services, Inc.; Bethesda (MD); Remote; USD 120,000 - 180,000; Full time

Job summary

Tunnell Government Services, Inc. seeks a Toxicologist Subject Matter Expert to support FDA risk assessments for medical devices. The role provides technical authority, analyzes safety data, and contributes to scientific evaluations required for FDA reviews.

Ideal candidates hold a PhD in Toxicology or Biology and Chemistry with at least five years of relevant experience, familiarity with ISO 10993 standards, and the ability to work effectively in virtual, matrixed teams.

Qualifications

• PhD in Toxicology, or Biology and Chemistry.
• At least five years of experience in toxicology risk assessment.
• Experience with medical devices is highly desirable.
• Knowledge of toxicology principles and risk assessment.
• Familiar with in silico toxicology and computational risk methods is beneficial.
• Familiar with ISO 10993-1/17/18 and related standards.
• Board certification or related certifications are highly preferred.
• Ability to work independently and in matrixed teams.
• US Citizenship or Full Green Card holder.
• 100% telecommuting remote work.

Responsibilities

• Serve as technical authority in scientific analysis of the safety and effectiveness of medical devices for FDA review.
• Provide authoritative analyses of scientific data submitted to the FDA for medical device evaluations.

Skills

Excellent communication skills

MS Office proficiency

Remote work capability

Education

PhD in Toxicology or Biology and Chemistry

Tools

MS Office

Job description

Tunnell Government Services, Inc. seeks a Toxicologist Subject Matter Expert to support FDA risk assessments for medical devices. The role provides technical authority, analyzes safety data, and contributes to scientific evaluations required for FDA reviews.

Ideal candidates hold a PhD in Toxicology or Biology and Chemistry with at least five years of relevant experience, familiarity with ISO 10993 standards, and the ability to work effectively in virtual, matrixed teams.