The Sr. Manager/Assoc. Director within Nonclinical Safety will support the research and development of new ophthalmic medical device products as well as maintenance of business activities by ensuring that adequate documentation exists for all new and existing products to meet existing and emerging regulatory requirements, particularly the EU Medical Device Regulations (EU MDR) and ISO 10993 series.
Represent the Nonclinical Safety function within site, managing a team of scientists and serving as core team project member. Additional responsibilities include authoring and providing guidance on risk assessments (products, formulations/ingredients/materials, impurities, leachables and extractables), authoring regulatory documents, and interacting with Health Authorities.
Specific Job Duties:
Scope of Position:
This position is primarily focused on the development of new products as well as supporting maintenance of business for surgical products/equipment. Position will manage small group of scientists within site.
The position interacts directly with B+L functional groups including R&D groups in Rochester, St. Louis, Irvine and Clearwater. Also Regulatory, Analytical Chemistry, and Quality groups in the various business units.
The position requires a Master or PhD degree in toxicology or a related biological science field, or regulatory affairs.
The position requires a minimum of 5 years (Sr. Manager) or 8 years (Assoc. Director) in regulatory toxicology for medical devices; experience with ophthalmic surgical products/equipment highly preferred.