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This principal scientist position within Nonclinical Safety will support the research and development of new ophthalmic products as well as maintenance of business activities 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:
- Design strategies, plan, and manage nonclinical safety/biocompatibility programs
- Represent the Nonclinical Safety function on project teams
- Conduct risk assessments on products, ingredients/materials, impurities and formulations, and author safety assessment documents
- Oversee and evaluate activities of contract research organizations
- Prepare necessary documentation (e.g. Central File Reports) to support regulatory submissions
The position requires a Master or PhD degree in a related field, including toxicology or other biological sciences.
The position requires a minimum of 5 years in regulatory toxicology for medical devices; experience with ophthalmic surgical products/equipment highly preferred.
- Expert in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993
- Experience working with global regulations and requirements, especially the EU Medical Device Directives (MDD) and Medical Device Regulations (MDR).
- Experience in managing nonclinical safety studies at external facilities
- Experience working in Design Control (e.g. PDP) environment
- Strong computer and general software skills; familiarity with Documentum preferred
- Strong oral/written communication skills
To apply for this job email your details to email@example.com
Senior Consultant & Client Partner
With a background in leadership and sports management, Tim Coykendall is exceptionally driven to help individuals and organizations reach their most ambitious professional goals. He has a unique ability to pinpoint cultural alignment as he evaluates talent for critical executive leadership positions across the country.