Responsibilities: Perform core regional quality systems activities as assigned (e.g., revising procedures, assisting in inspection readiness) following defined procedures. Develop, improve, and revise regional quality system SOPs. Condu...
Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs act...
Responsibilities: Supports necessary regulatory activities required for product market entry. Preparation of regulatory submissions for Electrophysiology Mapping and Imaging devices to achieve departmental and organizational objectives. ...
Responsibilities: Author technical reports, policies, and Standard Operating Procedures. Author/review, format, and revise reports, protocols, analytical method validations, and CMC sections for regulatory submissions. Author investigat...