Principal Toxicologist

Location: Northfield

Job Summary
Serve as a subject matter expert, providing strategic guidance and scientific expertise to cross-functional teams, including R&D, quality, and regulatory affairs. This senior-level position requires deep expertise in toxicology, a strong understanding of international regulations, and excellent leadership skills. This position ensures product safety and leads risk mitigation efforts in the form of biological evaluations, chemical characterization, and toxicological risk assessments for medical devices, OTC, and cosmetic products.

The role involves guiding product development teams and mentoring junior staff to ensure patient safety and product quality.

Job Description
Responsibilities:

• Provide strategic input for regulatory submissions (e.g., 510(k), CE marking, PMDA) and interact with global regulatory bodies.
• Risk Assessment and Evaluation:
  Conduct and lead toxicological risk assessments for new and existing medical devices, components, and materials. This includes creating Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs) in accordance with ISO 10993 and responding to questions from regulatory agencies.
• Develop and implement strategies for biological evaluation to ensure compliance with global regulatory standards, such as those from the FDA and EU MDR.
• Stay current with emerging trends and advancements in the field of toxicology and product safety and integrate predictive toxicology tools into safety assessments.
• Mentor and guide junior toxicologists and scientists, fostering technical growth and knowledge sharing.
• Conduct and interpret chemical characterization (e.g., E&L studies, ISO 10993-18, ISO 18562), SAR/QSAR modeling, and guide biocompatibility testing under GLP requirements.
• Serve as a subject matter expert, providing strategic guidance and scientific expertise to cross-functional teams, including R&D, quality, and regulatory affairs. Advise on potential risks and hazards associated with product materials and processes.
• Independent problem solver who can use a methodical approach to develop solutions and make recommendations.
• Represent the organization in external forums, regulatory meetings, and industry working groups (e.g., ASTM, ISO).

Qualifications:

• Bachelor's degree in Toxicology, Pharmacology, or a related scientific field
• 10+ years of experience in toxicology, with a significant focus on medical devices or a closely related industry (e.g., pharmaceutical, biotech) and toxicological risk assessments, biocompatibility assessments, and chemical characterization.
• In-depth knowledge of toxicology principles, risk assessment methodologies, and global regulations like ISO 10993, ISO 18562, ISO 14971, FDA, and EU MDR.
• Must possess excellent communication (written and verbal), leadership, and problem-solving skills. The ability to manage multiple projects simultaneously and work effectively in a matrixed environment is critical.

Preferred Qualifications:

• A Diplomate of the American Board of Toxicology (DABT) or equivalent certification is highly desirable.
• Experience of quality audit by external regulatory bodies (FDA, EU Regulatory body, etc.).
• Experience in solving practical problems and dealing with a variety of concrete variables in situations where only limited standardization exists.
• Experience communicating with internal and external business partners and cross functional teams with various audiences.
• Must be team oriented, with the ability to work well on common deliverables with diverse cross-functional teams and to interact at the highest professional manner with excellent communication skills, both verbal and written, and interpersonal skills to successfully partner on varying levels ranging from cross functional to global multi-site.
• Self-starter, independent worker, detail oriented with critical thinking and excellent organizational, analytical and problem-solving skills.
• Strong time management skills to prioritize, organize track details and meet deadlines for multiple projects with varying completion dates.
• Ability to influence and motivate others to drive results in a multi-location and matrixed environment.
• Ability to manage multiple projects in…