Regulatory Affairs Specialist (Hybrid)
Stryker
**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.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
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