This principal scientist position within Nonclinical Safety will support the research and development of new ophthalmic products as well as maintenance of business activities for B+L Surgical Business Unit through the design of biocompatibility assessment strategies, execute toxicology studies designed to meet regulatory guidelines, particularly ISO 10993, and author biocompatibility safety assessments and other regulatory documents.
This person in this position will serve as core a team member, representing the Nonclinical Safety function, on surgical project teams. Additional responsibilities include providing guidance and risk assessments (products, formulations/ingredients/materials, impurities, leachables and extractables), authoring regulatory documents, and interacting with Health Authorities. Other responsibilities may include work on vision care products (e.g. contact lenses and contact lens care) and other medical devices as needed.
Specific Job Duties:
The position requires a Master or PhD degree in a related field, including toxicology or other biological sciences.
The position requires a minimum of 3 years in regulatory toxicology for medical devices; experience with ophthalmic surgical products/equipment highly preferred.