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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:
Skills Required
- University or bachelor's degree, or equivalent, in a technical-related discipline
- 0–2 years of related experience
- Spanish-English bilingual proficiency at 80%
- Strong organizational skills
- Project management skills
- Problem-solving skills
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
