Job Description: Develop and apply intermediate knowledge and understanding of regulatory requirements, legislation, processes and procedures to support new product development and product lifecycle activities. Act as a liaison between the division and in country regulatory representatives to enable and maintain global market access. Acts as a catalyst for globalization. Viewed as departmental resource. Job Responsibilities: Develops and applies intermediate technical leadership skills to plan and implement activities in support of global regulatory strategy, submissions and renewals Assesses regulatory intelligence to develop intermediate regulatory knowledge and contribute to the development of global regulatory strategies, providing regulatory input to new product development and product lifecycle planning Supports the New Product Submission Planning process for worldwide product registrations. Demonstrates developing project management, regulatory writing, coordination, and execution skills, with emphasis on regulatory submissions and maintenance activities. Recommends changes in procedures when indicated including ways to incorporate global requirements. Acts as a point of contact for Regulatory teams in global distribution networks. Plans, conducts and executes assignments, reviewing progress and evaluating results. Job Requirements: Typically a minimum of 3 years experience RAC certification preferred B.S. or B.A. Degree required. Basic to intermediate understanding of quality system regulations, medical device legislation and other regulations related to global market access preferred. Candidates with multilingual communication skills preferred Job Details: Company: Stryker Vacancy Type: Full Time Job Location: Indianapolis, IN, US Application Deadline: N/A Apply Here careers-trivia.com
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