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.
... investing time inourown health and fitness.We believe that everyone has untapped potential... ...opportunities with you. What makes Personal Training with Equinox stand out?... ...over twenty years EFTI has elevated our trainers to design comprehensive client fitness programs...
...and direction of the Vice President of Operations, the Director of Quality collaborates with management to develop plans and implement policies and procedures... ..., compliance, and high performance. Serves as the Risk Manager for the organization and implements a risk management...
...earning potential with a proven, high-demand product line. Outside Sales Representative - Tri-Cities, WA Are you an energetic and... ...earning potential? We are seeking a driven individual to join our B2B outside sales team in the Tri-Cities, WA area. Who We Are With...
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...: POSITION SUMMARY: Avennia Winery is looking for a motivated, dedicated, hardworking individual to help with the upcoming harvest. Avennia is set to crush 175 tons. We work with some of the most iconic vineyards in the state and source a large variety of grapes...