At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

REQUIRED KNOWLEDGE AND EXPERIENCE:

• Bachelor’s or master’s degree. Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or field related experience.
• 2 years of relevant experience in job offered or a similar role.
• 
  
  
  
• Advance proficiency in Spanish and English required (reading, writing and speaking).

• Portuguese desirable.
• Fluent English
• Regulatory affairs experience in medical devices or pharmaceutical industry
• 
  
  
  
• Ability to work in matrix structured organization.
  
  Someone who is proactive and has problem-solving skills as well as eager to learn and open to feedback.

PHYSICAL JOB REQUIREMENTS

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

• Design monographs for Brazilian submission under the Sr. RAS instruction
• CFGs, FSC or ISOs or any legal document management & distribution
• Translations management for clusters under their responsibility
• Build dossiers for all Latam countries. (For Mexican dossiers each RAS need to perform a double check).
• Follow up with Business Partners and Operating Units to assure submission planning.
• Answer Government questions
• Follow up RACs/RANs that need submission and prior approval. They will support RAN’s management under RA Manager instruction.
• Approval notification to OU, international, regional and local team