Regulatory Affairs Specialist (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.

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