Regulatory Affairs Specialist in Mexico City at Stryker Corporation

Date Posted: 7/15/2019

Job Snapshot

Job Description

Who we want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
  • Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
  • Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.
  • 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.
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

The Regulatory Affairs Specialist coordinates and documents internal regulatory processes such as new registrations, registrations, renewals of licenses, updates of registrations and registrations. You should compile and prepare the materials for submission to regulatory agencies.

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.

• Colaboration 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.

• Additional, Responsible for the Planning of Registration for new acquisitions.

• Evaluate and ensure the necessary actions to reduce the impact of Change Notification process of the different manufacturing sites.

• Communication and Representation of Stryker at COFEPRIS for submission and collection of Resolutions.

• Responsible for the strategy for the submission of Import Permits.

• 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 will need

  • Bachelor or Engineering, Biological Pharmaceutical Chemistry or similar, indispensable to have title and ID.
  • 3-4 years of experience in regulatory processes
  • Advanced knowledge of Office software.
  • Knowledge in sanitary regulation; preferable of Medical devices.
  • Advanced English.
  • Must be able to use tools and resources related to product registration.

Work From Home: No

Travel Percentage: None

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