Principal Toxicologist

About the role

Our Surgery team is looking for a Principal Toxicologist, Toxicology & Biocompatibility to support our medical devices business. This role must be based within a commutable distance of Raritan, NJ (strongly desired), or Cincinnati, OH, and will work a Flex/Hybrid schedule with 3 days per week on-site.

Responsibilities

• Evaluates medical device products and materials for biological safety per international medical device regulations and standards, GLP (US FDA Good Laboratory Practice) guidelines, and internal procedures.
• Designs, initiates, coordinates, and interprets laboratory investigations for biocompatibility and toxicology studies for medical device materials and products.
• Applies technical expertise to solve biocompatibility problems related to the ISO 10993 standards and regulatory authority requirements for product safety.
• Liaises with internal and cross-functional team members to review existing product documentation and coordinates, together with more senior staff, biocompatibility test strategies to ensure appropriate planning and execution of required testing and completion of relevant deliverables.
• Reviews, interprets, and summarizes testing data and ensures appropriate documentation and coordination of central documentation procedures required for risk assessment report completion.
• Interacts closely with and provides technical guidance and expertise to internal stakeholders (e.g., R&D, Preclinical, Clinical Affairs, Regulatory Affairs, Medical Safety, Manufacturing, Quality Engineering, and Supplier Management) and external partners on medical devices across the entire product lifecycle.
• Supports regulatory/notified body requests as part of audits and file/product submissions/reviews in applicable markets.
• Directly interacts with notified body (TUV, BSI) and regulatory representatives.
• Performs other duties assigned as needed.

Requirements

• An advanced degree (MS or Ph.D.) in Toxicology or a related scientific discipline is required.
• A minimum of 6 years in relevant industry in medical devices is required.
• A minimum of 8-10 years of experience in toxicology and biocompatibility assessments and evaluation in a medical device, pharmaceutical, and/or consumer product company or similar combination of professional training and multi-year experience in the industry is required.
• Experience in medical devices is strongly preferred.
• Experience working in a regulated environment of medical device safety and supporting product submission and audit is required; support for worldwide market registration is preferred.
• Experience in absorbable biomaterials for implantable medical devices, including experience in medical device material degradation and toxicokinetics, is required.
• Knowledge of toxicology & biocompatibility assessment of medical devices, coordination, and interpretation of biocompatibility and chemistry studies per relevant guidelines and requirements is required.
• Knowledge of laboratory animal care & use practices is strongly preferred.
• Understanding of manufacturing processes of medical devices is strongly preferred.

Qualifications

• Ability to work collaboratively as a team member across various functions and disciplines in a challenging and changing environment is required.
• Interacts appropriately with all internal and cross-functional partners and demonstrates effective use of conflict resolution skills.
• Demonstrates technical leadership and mentorship.
• Demonstrates behavior qualities including confidence, transparency, integrity, innovation, passion, patience, and tenacity.
• Excellent written and verbal communication skills. Depending on location, local language skills are preferrable.
• Proactive and self-directed performance in an unsupervised environment and tenacity to overcome major obstacles are required.
• Able to drive problem resolution efficiently and proactively through effective use of analytical and problem-solving skills.

Skills

• Ability to work collaboratively as a team member across various functions and disciplines in a challenging and changing environment is required.
• Interacts appropriately with all internal and cross-functional partners and demonstrates effective use of conflict resolution skills.
• Demonstrates technical leadership and mentorship.
• Demonstrates behavior qualities including confidence, transparency, integrity, innovation, passion, patience, and tenacity.
• Excellent written and verbal communication skills. Depending on location, local language skills are preferrable.
• Proactive and self-directed performance in an unsupervised environment and tenacity to overcome major obstacles are required.
• Able to drive problem resolution efficiently and proactively through effective use of analytical and problem-solving skills.