Regulatory Affairs Specialist

hace 1 día

Mexicali, Baja California, México Medtronic A tiempo completo

**About Medtronic**

At Medtronic, we're a mission-driven leader in medical technology and solutions. Our legacy of integrity and innovation has enabled us to make a meaningful impact on healthcare access and equity worldwide.

**A Day in the Life**

As a Regulatory Affairs Specialist, you'll play a critical role in championing healthcare access and equity for all. Your expertise in Mexican and LATAM regulations for medical devices will be instrumental in driving the regulatory process for product licensing.

**Key Responsibilities**

  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections.
  • Leads or compiles all materials required in submissions, license renewal, and annual registrations.
  • Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
  • Monitors and improves tracking/control systems.
  • Keeps abreast of regulatory procedures and changes.
  • May direct interaction with regulatory agencies on defined matters.
  • Recommends strategies for earliest possible approvals of clinical trials applications.

**Requirements**

  • Bachelor's degree.
  • 2+ years of regulatory affairs-related experience.
  • Fluent in English.
  • Experience working with regulations/Cofepris.
  • Experience in a regulatory affairs role, either as a regulatory product specialist, regulatory international, or regulatory operations role.
  • Advanced knowledge of spreadsheet/graphing, including knowledge of Microsoft Office applications, including Word, Excel, PowerPoint.
  • Effective project management skills.
  • Ability to create and work in cross-functional partnerships.
  • Effective negotiation skills.

**Nice to Have**

  • Regulatory Affairs Certification (desired).
  • SAP experience.
  • Experience/use of PowerBI and Smartsheet.

**What We Offer**

  • Competitive salary and benefits package.
  • Flexible working environment.
  • Annual Incentive Plan % depending on company results.
  • Pension scheme and group discount on healthcare insurance.
  • Training possibilities via Cornerstone/Skills Lab.
  • Employee Assistance Program and Recognize (our global recognition program).

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