Staff Toxicologist - Remote

Overview

The Staff Toxicologist will play a critical role in authoring and guiding toxicological risk assessments for medical devices and combination products. This position involves performing high-level biological safety evaluations, providing strategic input on regulatory submissions, and mentoring junior staff members as needed.

In Short

• Perform toxicological risk assessments for medical devices and combination products.
• Coordinate with internal laboratories to ensure high-quality data.
• Guide regulatory submissions for FDA and EU compliance.
• Act as a primary contact for regulatory agencies.
• Contribute to the development of new protocols and methodologies.
• Mentor junior toxicologists.
• Present complex data to cross-functional teams.
• Participate in initiatives to improve internal processes.
• Provide expert input for training programs.

Requirements

• Master’s degree in Toxicology or related field.
• Board Certified Toxicologist or pursuing certification.
• 4-6 years of experience in toxicology.
• Advanced experience with regulatory submissions.
• Knowledge of global regulatory environments.
• Familiarity with toxicology databases and software tools.
• Knowledge of Good Laboratory Practice.
• Experience in developing toxicological evaluations.
• Strong knowledge of FDA and EU regulations.
• Strong technical writing experience.

Benefits

• Collaborative work environment.
• Opportunity for professional growth.
• Engagement with innovative projects.
• Mentorship opportunities.
• Flexible work schedule.