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.
...meetings Create a positive environment through encouragement and teamwork Oversee video and still photography production and post-... ...have experience in: ~2-5 years of agency experience and an online portfolio demonstrating past success in conceptual advertising...
...upgrades, and implementations. Maintain accurate records of work performed, issues, and resolutions using the company's ticketing... ...remote support and troubleshooting for users working from home or in the field. Train and mentor junior support technicians...
...re looking for a reliable and proactive Receptionist / Hospitality Specialist to be the warm and welcoming face of our firm. This full-time role is essential to delivering a seamless, first-class experience for our clients, visitors, and staff. Shift: Monday-Friday...
A leading global investment firm is seeking a Managing Editor to lead and evolve its flagship daily macroeconomic commentary. This is a rare opportunity to shape and front one of the most influential daily products in global marketsserving an audience of senior investors...
...customize the entire process to address your client's unique needs. From goal setting to creating their workout plan, behavior coaching, nutrition recommendations and so much more.Train your clients ANYWHERE. We are the nation's largest in-home, virtual, and remote personal...