• 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
...Hours/Week Saturday and Sunday 6am-2pm Monday and Tuesday 8am-4pm Wednesday-Friday off Under general direction from the shelter supervisor, oversees daily operations of shelter and assists residents in their day-to-day requirements. Accountabilities...
...Title: Waste Project Manager Location: Chicago, IL 60633 Direct Hire Starting Pay: Up to 80k depending on experience Excellent... ...Assist Environmental with response to chemical spill incidents by placing adsorbents on liquids, sweeping or vacuuming solids...
...Role Description: Conducts project initiation activities to identify current and future state requirements. Works with business and Information Systems staff to determine needs and produce Requirements Definition document that completely and clearly defines the...
...applying your skillsets toward a new career with high growth and earning potential? Arrow Lift specializes in installing/servicing accessibility and lift systems (elevators, stairlifts, etc.). We have an exciting and challenging opportunity for an entry-level Elevator & Lift...
Insight Global is seeking a skilled Industrial Mechanic to support a manufacturing client in Petersburg, VA 23805 full-time. Job Description: Diagnose and repair mechanical equipment by observing operations, dismantling devices, inspecting parts, and performing...