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.
...group we responsively provide a comprehensive range of boutique fund services delivered from our Jersey, Luxembourg, Cayman Islands, Bahamas, Isle of Man, and United States offices. Our approach is personal and tailored and we aim to be more than just a service provider,...
Regional Sales Manager Process EquipmentTerritory: Western half of the USLocation:... ...dynamic territory. Your work will influence pharmaceutical innovation and advanced manufacturing... .... Please include Job#19318 .Seniority level Entry levelEmployment type Full-timeJob...
...includes: \n \n Possible opportunities to supervise Health Psychology trainees based on fellow availability and interest. \n... ...hospitaland considered one of the nation's leading hospitals, teaching institutions and referral centers. \n View Full Job Description...
...A Digital Marketing Manager is responsible for developing and executing comprehensive digital marketing strategies across various online channels like social media, email, website content, and paid advertising, aiming to increase brand awareness, drive website traffic,...
...maintaining a positive attitude Maintain confidentiality of all company and patient information in accordance with HIPAA regulations and DaVita policies Consistent and punctual attendance as scheduled is an essential responsibility of this position Qualifications:...