Sr. Regulatory Affairs Specialist, México City (Xico)

We are searching for the best talent for a Sr. Regulatory Affairs Specialist in Mexico City. We are developing the next generation of smarter, less invasive, more personalized treatments.

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.

Responsibilities

• Develop 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.
• Resolve complex problems relating to licensing between the company and licensing regulators.
• Provide regulatory support and expertise across all functional areas involved in projects.
• Act as liaison between regulatory agencies and project teams to expedite approval processing by addressing complicated issues.
• Compile complex product approval packages and prepare paper and electronic submissions.
• Participate and represent department at project meetings.

Qualifications

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 general 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.

Required 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

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 DevelopmentRegulatory Environment
• Risk Assessments
• Teamwork

Languages

• Spanish (native)
• English (intermediate/advanced – ~80%)