Staff Toxicologist

Primary Responsibilities:

• Perform toxicological risk assessments for chemical characterization, extractables/leachables (E&L) data, and other safety evaluations for medical devices and drug-device combination products, including literature reviews, computational modeling, and risk assessment strategies.
• Coordinate and collaborate with internal laboratories to review and interpret test lab reports and ensure high-quality data for regulatory submissions.
• Guide regulatory submissions for FDA (CDRH) and EU MDR compliance, with a focus on navigating and meeting regional and global requirements.
• Act as the primary point of contact for regulatory agencies and serve as an expert in all matters related to medical device toxicology.
• Contribute to the development of new protocols, strategies, and methodologies for toxicological assessments in line with evolving industry standards and regulatory requirements.
• Mentor and provide technical guidance to junior toxicologists as needed, ensuring high-quality work and adherence to regulatory standards.
• Present complex toxicological data to cross-functional teams, senior leadership, and external stakeholders in a clear, concise, and actionable manner.
• Participate in initiatives to improve internal processes, with a focus on enhancing efficiency, compliance, and the overall effectiveness of the toxicology department.
• Provide expert input for the development and implementation of training programs and resources to enhance the team’s knowledge and performance.

Requirements:

• Master’s degree or equivalent in Toxicology or a related field.
• Board Certified (DABT) Toxicologist or actively pursuing certification.
• 4-6 years of relevant experience in toxicology, with at least 3 years specifically focused on medical device toxicological risk assessments and regulatory submissions.
• Advanced experience with regulatory submissions or exposure to industry-specific toxicology studies.
• Advanced knowledge of global regulatory environments and emerging trends in medical device toxicology.
• Familiarity with toxicology databases and software tools.
• Knowledge of Good Laboratory Practice (GLP) or other quality assurance standards.
• Proven experience in developing and leading toxicological evaluations for medical devices, including chemical characterization and biological safety evaluations.
• Strong working knowledge of ISO 10993, ISO 18562, FDA (CDRH) regulations, and EU MDR requirements.
• Extensive experience with chemical characterization testing, extractables/leachables studies, and risk assessment processes.
• Experience with direct interaction and communication with regulatory agencies (FDA, EU) is highly preferred.
• Strong technical writing experience, particularly in regulatory submissions, safety assessments, and scientific reports.
• Strong leadership skills with the ability to mentor, guide, and inspire a team of toxicologists.
• Highly organized with excellent problem-solving skills, capable of managing multiple projects and deadlines with high performance orientation.
• Strong verbal and written communication skills with the ability to present complex scientific data in an accessible and persuasive manner.
• Advanced computer skills, including proficiency in Microsoft Office Suite and toxicological databases/software.
• Adapts to change when directed.
• Excellent interpersonal communication and influencing skills as well as experience working collaboratively with clients and employees.
• Provides clear and appropriately detailed project updates.
• Ability to escalate to management when needed.
• Requires willingness to work a flexible schedule

Behaviors:

• Customer Focus, Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning, Time Management 

Supervisory Responsibilities:

• This position will have no supervisory responsibilities. 

Work Environment/Physical Demands

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds.