In this role, you will support the development of compliant electronic systems; plans, prepares, and tracks regulatory electronic documents and submissions ensuring conformance with regulatory requirements, guidelines, internal standards and timelines.
In this role, the selected candidate will be responsible for implementing and maintaining the effectiveness of the quality system; responsible for compliance with applicable Corporate and Divisional Policies and procedures.
In this role, the selected candidate will evaluate complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals.
In this position, you will lead projects which serve to develop, apply, and revise procedures to maintain and improve quality compliance and standards as well as review and approve concessions, non-conforming product and corrective actions as denoted by applicable regulations and procedures.
In this role, you will be responsible for
working with Marketing and Quality Assurance, determine and execute International and Domestic regulatory submission and approval requirements by compiling and submitting moderately complex registration documentation. Maintain current and complete international country registration files.