• Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy
• Remediation of regulatory documentation in accordance with relevant regulatory requirements for US 510(k)
• Remediation of EU MDR Technical Documentation File in accordance with relevant regulatory requirements for Class IIa medical device
• Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies
• Provides guidance to integrate regulatory considerations into global product entry and exit strategy
• Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles
• Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations
• Negotiates with regulatory authorities on complex issues throughout the product lifecycle
• Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution
• Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
• Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
• Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions
• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions
• Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans
• Provides regulatory guidance on strategy for proposed product claims/labeling
• Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims
• Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees
Provide exceptional customer service in a safe and clean environment to ensure the customer s return visit. Treat customers/employees in a fair and ethical manner, promoting an inclusive work environment, being a responsible member of the community, providing the right...
...driven by working in a healthcare setting. Requirements Review patient chart in preparation for upcoming exam and/or surgeries ... ...Communicate with patient providers outside of SMOMS to receive medical clearances, x-rays, treatment plans, etc. All assistants...
...sankahset skeset n : The time between late afternoon and early... ...tension between day and night to a new advanced contemporary... ...people and fashion to join our team part time. This is a leadership position... ...availability ~ Ability to work at least 30 hours / week ~ Customer...
...who loves hands-on content creation, has an eye for detail, and can write in a clear, concise style thats appropriate for 1215 year-old students. The ideal candidate has 37 years of experience and a background in education or instructional design, with a proven...
...Registered Nurse Location: Harvey, LA (Jefferson Parrish) Schedule: Full-Time | School-Based BlazerJobs is proud to partner with a school district in the Harvey, LA area to find a dedicated Registered Nurse (RN) for a full-time position supporting students and...