Regulatory Affairs Specialist in Mexico City at Stryker Corporation

Date Posted: 2/16/2020

Job Snapshot

Job Description

What We Want

  • Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to be ready for what’s next.

What You Will Do

Execute the processes that ensure the compliance of the products with the local norms for their commercialization, keep the records updated by product. ​

Important Elements:

1. Compliance

  • All business and related matters must be carried out in accordance with all laws and regulations, including the Foreign Corrupt Practices Act (FCPA), the Stryker Code of Conduct and the highest ethical standards.

2. Regulation Issues

  • Validation of product registration lists and update the tools provided by Stryker to ensure product release by the corresponding Design Division.
  • Ensures that all materials available for sale in the country are registered in the necessary official dependencies.
  • Collaboration in associations and technical committees to meet and learn about changes in regulations of the industry that have an impact in the area.
  • Execution of the current Registration plan, regarding all the franchises and business needs.
  • Communication and Representation of Stryker at COFEPRIS for submission and collection of Resolutions.
  • Analyze the regulatory environment of the country to identify updates and impacts related to the area.
  • Responsible for the authorization of advertising materials requested by the business.
  • Performing Post Marketing Surveillance Reports and informing the authority adverse effects.

3. Organizational Capabilities

  • Lead continuous improvement activities.
  • Regulatory / documentary support to other functional areas (Quality, Tenders, Operations and Sales).

What You Need

  • Bachelor’s degree: Engineering, Biological, Pharmaceutical, Chemistry or similar, indispensable to have title and ID;
  • 2-3 years of experience in regulatory processes, quality assurance knowledge preferred;
  • Advanced knowledge of Office software;
  • Knowledge in sanitary regulation on Healthcare’s company;
  • Advanced English is mandatory;
  • Must be able to use tools and resources related to product registration.

Work From Home: Occasional

Travel Percentage: 10%

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