Responsibilities: Prepare and submit regulatory documentation for domestic and international markets, ensuring compliance with applicable regulations (i.e. PMA, HDE, 510ks, letters to file, and Tech Docs). Provide regulatory direction to development project teams as a core team member. Develop regulatory strategy for new products, evaluating risk of proposed strategies and offering solutions. Review proposed labelling for compliance with applicable global regulations. Review proposed product changes for impact on regulatory status of the products. Contribute to the development and maintenance of Instructions for Use and Surgical Technique Guides. Review and evaluate promotion and advertising material for compliance with applicable regulations. Communicate with regulatory and governmental agencies. May provide training and/or guidance to entry-level associates, analysts, interns, and specialists. Support additional regulatory compliance items as required by regulations and as needed by the RA team. May provide training and/or guidance to entry-level associates, analysts, interns, and specialists. Requirements: Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.
...Required Early Morning Availability About the Role: In this role, you will deliver excellent customer service and consistent execution of store operations. You will efficiently process freight, replenishment, and omni channel operations. What You'll Do: Receive...
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...evaluating HR policies, programs, and practices Supervising and directing two Human Resources Generalists Maintaining and enhancing the HR department's effectiveness and service delivery Managing talent acquisition, recruitment, and onboarding processes Handling...
...Job Summary ~ A Hospital Care Aide (Sitter) is a paraprofessional employee, trained to provide supervision, companionship, environmental... ...support assistance. Reports changes in condition of patient and any safety issues to unit staff immediately. Population served...
...local and close to our customers. Read more at Location: Phoenix, AZ Division: Air & Sea US Job Posting Title: Freight Forwarder, Ocean Import Time Type: Full Time Duties and Responsibilities Manage the importation of goods by ocean,...