Regulatory Affairs Specialist (Hybrid)

Posted:
9/26/2025, 3:17:07 AM

Location(s):
Mexico City, Mexico

Experience Level(s):
Junior ⋅ Mid Level

Field(s):
Legal & Compliance

Work Flexibility: Hybrid

What you will do

  • Ensure compliance of products with local norms and maintain updated product records.
  • Validate product registration lists and update Stryker’s regulatory tools.
  • Manage local licenses and execute the Registration Plan across all franchises.
  • Represent Stryker at COFEPRIS for submissions and collection of resolutions.
  • Monitor regulatory changes through associations and technical committees.
  • Authorize advertising materials and support post-marketing surveillance reporting.
  • Provide regulatory and documentary support to Quality, Tenders, Operations, and Sales.
  • Lead continuous improvement activities in regulatory processes.

What you need

Required

  • Bachelor’s Degree.
  • Minimum 2 years of experience in regulatory processes in a medical device industry.
  • Advanced/Conversational English skills.
  • Intermediate knowledge of Microsoft Office.
  • Knowledge in sanitary regulation on Healthcare’s company. 
  • Ability to use tools and resources related to product registration.

Preferred

  • Quality assurance knowledge.

Travel Percentage: 10%