Regulatory Affairs Specialist (Hybrid)

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%