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.
A leading pharmaceutical company is seeking a Medical Science Liaison for the Pacific Northwest territory. Responsibilities include building relationships with health care providers, strategic planning, and providing scientific information. Candidates should have a PharmD...
...each tool in your custom tool-kit Problem-solve repairs with creativity ~ We are looking for someone who has experience as a tile setter. You will use your knowledge of different types of tile (porcelain, ceramic and natural stone) to create repair solutions....
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...those under our care and for those in communities throughout Minnesota. Working Title: Senior Financial Consultant Job Class: Accounting Officer Coordinator Agency: Department of Employment and Economic Development Job ID : 90917 Location : St. Paul...
...Paid time off Profit sharing Vision insurance About the Role: Dallas Reading and Language Services is seeking a Bilingual Speech Language Pathologist Assistant to join our team. We are a leading provider of speech and language therapy services in the Dallas...