Regulatory Operations Specialist for Medical Technology

hace 5 días


Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo

At Medtronic, a global leader in healthcare technology, you can embark on a lifelong journey of exploration and innovation, making a meaningful impact on people's lives. Our mission to alleviate pain, restore health, and extend life unites a diverse team of passionate professionals.

About the Role

We are seeking an experienced Senior Regulatory Operations Specialist to drive collaboration in interconnected processes, GTS strategy activation, and implementation, as well as support/lead transformational projects. This is a remote-based position located in Colombia.

Key Responsibilities
  • Prepare, publish, and deliver high-quality submissions, including initial large marketing authorization applications and electronic common technical documents (e-CTD).
  • Support activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing plans, and providing input to system designs.
  • Evaluate external vendors' efficiency and effectiveness, ensuring continuous process improvement measurements.
  • Prepare, submit, track, index, and archive paper and electronic submissions, including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.
Requirements
  • Bachelor's degree.
  • Five years of experience in regulatory affairs or related areas.
  • Fluent in English.
  • Proficient in Microsoft Office (Outlook, Excel, Word, PowerPoint).
  • Growth and global mindset.
  • Able to transform knowledge into solutions (automations/digitization).
  • Experience with SAP and GTS is advantageous.
Benefits & Compensation

This position offers a competitive salary ranging from $90,000 to $120,000 per year, depending on experience, plus a comprehensive benefits package, including flexible time-off, medical, dental, and vision insurance, 401(k) matching, and more.

About Medtronic

Medtronic is a pioneer in global healthcare technology, driven by a passion to make a difference in people's lives. We are committed to innovation, quality, and excellence, and we strive to be a trusted partner in the healthcare community.



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