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**Job Function: **
Regulatory Affairs Group
**Job Sub Function: **
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Mexico City, Mexico
Job Description:
About MedTech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
We are searching for the best talent for Sr. Regulatory Affairs Specialist, Mexico City
Purpose:
Responsible for facilitating the submission of product approval documents within the filing requirements by acting as liaison between regulatory agencies and project team. Expedites approval processing by addressing issues and ensuring compliance with government regulations and interpretations
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 complex problems relating to licensing between the company and licensing regulators.
· Provides regulatory support and expertise across all functional areas involved in projects.
· Acts as liaison between regulatory agencies and project teams to expedite approval processing by addressing complicated issues.
· Compiles complex product approval packages. Prepares paper and electronic submissions.
· Participates and represents department at project meetings.
Qualifications / Requirements:
· University/Bachelors Degree or Equivalent within a technical related discipline.
· 4-6 years related experience. Can be a person with related experience and/or training or equivalent combination of education and experience, including a Master Degree.
· Leverages knowledge of the regulatory environment (including current and emerging regulations) to develop compliant regulatory strategies aligned with R&D and business objectives, considering global requirements.
· Executes regulatory strategies in line with applicable laws, regulations, and organizational requirements to obtain and maintain market authorization.
· Contributes to the development of effective, results-driven regulatory strategic plans aligned with business objectives.
· Demonstrates cultural awareness and adaptability across regions and countries.
· Serves as a technical expert within the function.
Competency Level:
· Applied Technical Knowledge – Leading
· Business Acumen – Applying
· Decision Making & Prioritization – Applying
· External Focus – Applying
· Leading and Influencing – Applying
· Persuasive Communication – Applying
Languages:
· Spanish (native)
· English (intermediate/advanced – ~80%)
**Required Skills: **
Preferred Skills:
Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork