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.
...individualized care planning and support. Health Education & Coaching : Delivers in-person and virtual health education sessions... ...evidence-based curricula to support patients self-management and wellness. Case Management & Support Services : Provides case...
...Job Description Job Description Are you the Ultimate Closer? Were hiring for our Promoter rolea part-time position that demands exceptional people-reading skills, confidence in engaging with hundreds of potential customers, and the ability to seamlessly educate...
...About The Position We're looking for an experienced Global People Partner to partner with senior leaders and support our team members. This role will also be critical to leading and managing strategic talent programs/initiatives to ensure successful implementation...
...top-performing marketing firm in New York City, is hiring an Entry Level Sales Success Representative to drive Verizons customer satisfaction... ...upsell opportunities, and optimizing each customer's experience with Verizon's wireless, internet, and home solutions. Role...
...Job Description Job Description Handyman Maintenance East Coast Real Estate Group, LLC Property Management company is looking for an A player to join our premier property management company as a Maintenance Technician. We dont just manage properties; we...