סקירה כללית
^^משרה זו נלקחה מ Career^^At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Yokneam, Israel Job Description: Under close supervision, identifies and prepares detailed international registration documentation that supports all stages of a medical device’s lifecycle, from initial product registration through end
• of
• life, ensuring that all documentation needs for international JNJ affiliates are met effectively. Applies methods for planning, directing, coordinating, and controlling the submission of international Regulatory documents to Regulatory agencies, including but not limited to responses to global Health Authority inquiries. Develops and sustains relationships with RA affiliates as their primary point of contact, contributing to the development and execution of local registration strategy. Contributes on cross
• functional project teams on international RA issues in the development of registration plans to ensure timely commercialization of new and modified products into international markets. Applies functional analysis and interpretation of new and changing government regulations to ensure compliance with regulatory/government standards. Maintains Regulatory Affairs databases and communications tools, including SharePoint site, Regulatory databases, request tracking systems, and electronic libraries. Writes, reviews and revises company SOPs as required. Coordinates with internal and external stakeholders to obtain necessary documentation required for international regulatory activities. Assists with global planning to help ensuring visibility, alignment, and optimal resource allocation. Communicates business related issues or opportunities to next management level. Follows all Company guidelines related to Health, Safety and Environmental practices as applicable. Ensures personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned, as needed. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Do Not Sell or Share My Personal Information Limit the Use of My Personal Information
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