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.
Experienced Ironworker Foreman McCarthy Fabrication, LLC is located in Sanford, Florida, and is seeking a Full-time field Foreman/Installer/fabricator. We are looking for a Foreman with strong leadership and excellent attention to detail, Extensive Knowledge and experience...
...High school diploma or GED equivalent or ten (10) years Structural Welder/Fitter experience will be considered.+ Minimum five (5) years... ...vision, depth perception and ability to adjust focus._Travel may require an employee or contractor to pass a TSA security checkpoint...
...Job Description - Mental Health Therapist (Individual Coach) Wonder is seeking a mental health coach to provide transition support centered on a holistic and integrative family systems approach. This is a part-time contract position. Who we are: Wonder was created...
...Acrylic Bath Installer Installation position available immediately! If you have installed bathrooms or kitchens for any large chain... ...have experience installing acrylic bath products, and must have drywall, mud and taping experience. Experience with one the...
...could cover multiple grade levels and subjects depending on the candidates skills and ability. Potential subjects include science, history, Latin, religion and PE.This position reports to the Headmaster and will work collaboratively to further the Joyful learning of students...