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.
We are Emerus, the leader in small-format hospitals. We partner with respected and like-minded health systems who share our mission... ...with licensing and accreditation standards. This Hospital Administrator will have operational oversight for both our Colleyville (550...
...Salary: $16.59 Hourly Location : 430 3rd Street, Farmington - 1 Job Type: Part-time Job Number: 000063A Department: Liquor Operations Opening Date: 06/16/2025 Closing Date: Continuous This position is responsible for providing retail sales and...
...Description: Under the guidance of a Certified Medial Assistant or Licensed Practical Nurse preceptor works at an entry-level, assisting RN, Physician and other providers... ...balance. Our comprehensive benefits include medical, dental, vision, life, and disability insurance...
GENERAL DESCRIPTION: Public Citizens Communications Office is seeking a Video Editor and Producer to join a creative, energetic and fast-paced team. The Video Editor will be responsible for conceiving and implementing video content for Public Citizens campaigns, including...
...DESCRIPTION: Mike O'Boyle - State Farm Agent is seeking a qualified... ...for the role of Life Insurance Position - State Farm Agent Team... ...appropriate products and services. Work with the agent to establish... ...for advancement within my office Work from home...