In this role, the selected candidate will prepare regulatory plans and worldwide compliance requirements for new or changes to existing devices; provide on-going support to teams for regulatory issues and questions.
In this role, the selected candidate will provide regulatory affairs input for product development and manufacturing, including review of specifications, protocols and reports, engineering change notices, nonconforming materials, product complaints, and product failure analysis.
The Regulatory Affairs Specialist provides global support for medical devices; is responsible for activities that lead to and maintain regulatory approval/clearance of these devices; and assesses the regulatory implications of changes to these devices.
In this role, the candidate will review and approve technical literature (labeling, IFUs, manuals, patient guides, etc.), sales and marketing literature, and reimbursement literature related to company products.