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Job Summary: The Director of Regulatory Affairs is responsible for developing, implementing, and leading both regional and international regulatory strategy for ZOLL products, while representing the firm in various cross-functional project teams. Reports to Vice President, Quality Assurance and Regulatory Affairs. Essential Functions: Global regulatory leadership for new and marketed medical device products. Liaison with the FDA and other regulatory agencies, as necessary, including arranging and attending face-to face meetings. Ability to formulate, create, and implement regulatory strategies and related activities needed to secure approvals. Preparation of PMA annual reports to FDA.