Description
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 GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Mexico City, MexicoJob Description:
OVERALL RESPONSIBILITIES:
Responsible for executing 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 medical 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 skills
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 - English 80%
CEO Behaviors :
Compete – 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:
