Regulatory Scientist, Toxicology

The Regulatory Scientist, Toxicology will support regulatory and testing strategies and standards development efforts, particularly as they relate to product approvals.  Through strong leadership and technical expertise, this position supports MED client needs by assisting, developing, and/or leading projects and programs aligned with scientific strategies for current and future products.

• Support work for clients by leading or contributing, as appropriate, to MED projects, helping to develop innovative solutions and providing support for the material selection and toxicology aspects of projects.
• Apply toxicological principles to meet complex regulatory requirements for product safety in regulatory submissions for client projects.
• Provide toxicological risk assessment expertise in assessing proposed changes to materials and processes used in construction of marketed products, as needed to support client work.
• Maintain high level of toxicological expertise by identifying and critically assessing emerging theories and methodologies and applying gained expertise to meet research objectives that align with strategic company objectives.
• May serve as a subject matter expert (SME) within their field of specialization to provide input on other programs, within Cook and the broader professional community.
• Provide critical review of testing protocols and final reports for scientific integrity and regulatory compliance.
• Provide evaluation, determination, and documentation of biological safety.
• Work and interact effectively and professionally with and for others.
• Strictly adhere to safety requirements.

• PhD with DABT, or eligible for DABT; field of study applicable to focus on toxicological and biological safety aspects of materials highly preferred.
• Strong understanding of human health risk assessment concepts and methods.
• Sound understanding of toxicology and/or the scientific basis for testing performed at Cook and generally accepted within the professional community.
• Experience with ISO 10993 is a plus,
• Pre-clinical or clinical drug safety experience is helpful.
• Ability to read, write, and compile technical documents.
• Excellent analytical and problem solving skills.
• Demonstrated ability to manage and execute multiple projects.
• Understanding of applicable guidelines and regulations.
• Effective oral, written and presentation - communication skills.
• Ability to work in collaborative and independent work situations and environments with minimal supervision.
• Ability to remain calm and receptive in fast paced situations.

Qualified candidates must be legally authorized to be employed in the United States. MED Institute does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN) for this employment position.