Analyst Reg Aff

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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Mexico City, Mexico Job Description: OVERALL RESPONSIBILITIES:   Responsible for   execu ting the submission   process   of product approval documents within the filing requirements .   Expedites approval processing by addressing issues and ensuring compliance with government regulations and interpretations       POSITION DUTIES & RESPONSIBILITIES:   Develops appropriate plans for the submission of product approval documents to ensure rapid and timely approval on medical devices and continued approved status of marketed medi cal devices.    Resolves moderately   complex problems.    Provides regulatory support and expertise   for moderately complex   projects   across all functional areas involved in projects.     Compiles   moderately   complex product approval packages .     Functional and Technical Competencies :     Leverages a working knowledge of the regulatory environment, including compliance, current and proposed laws, regulations and guidance, to prepare compliant Regulatory strategies that are aligned with R&D and business objectives of the company, including consideration of the global regulatory environment. Executes Regulatory strategies in compliance with relevant laws, regulations, and organizational requirements necessary to obtain, and maintain, legal market status.   Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.   Is aware of and receptive to cultural differences across regions and countries.   Serves as a technical expert   for low complexity projects   within job function   Strong organizational skills   Project management skills   Problem solving skill s   Fulfills competencies stated at the RA Global Competency Model   as follows:   Applied Technical Knowledge – Applying   Business Acumen   -  Learning   Decicion   Making & Prioritization - Applying   External Focus – Learning   Leading and Influencing –   Applying   Persuasive Communication - Applying   Bilingual Spanish -   Engli sh   8 0%     CEO   Behaviors   :     Co mpete   – Be insight driven to uncover unmet needs, effectively influences others by partnering with   them. Translates   insights into viable processes and solutions that create value   Execute   - Demonstrates conviction, proactivity and persistence when influencing others and overcoming resistance; gains support for one’s perspectives and ideas by establishing clear, positive links between ideas and business needs    Optimize   – Manages low   complexity projects independently     EDUCATION & EXPERIENCE REQUIREMENTS:     University/ Bachelors Degree   or Equivalent   within a technical related discipline    Generally   requires   0-2   years related experience                 Required Skills:     Preferred Skills: