Regulatory Affairs Expert
hace 3 días
Overview
At Medtronic, we pioneer healthcare technology to alleviate pain, restore health and extend life. Our team of 90,000+ passionate people experiment, create, build, improve and solve real-world problems.
About the Role
The Regulatory Affairs Specialist will lead regulatory activities for Latin America, ensuring compliance with regional regulations. This role requires collaboration with stakeholders, effective time management, and attention to detail.
Responsibilities:
- Plan and execute regulatory strategies for LATAM, including initial submissions, amendments, and changes.
- Design and manage monographs for Brazilian submissions.
- Coordinate translations for clusters under responsibility.
- Build dossiers for all LATAM countries, ensuring accuracy and completeness.
- Communicate effectively with Business Partners and Operating Units to ensure submission planning.
- Answer government questions and follow up on RACs/RANs that need submission and prior approval.
Requirements
To succeed in this role, you should have:
- Bachelor's or Master's degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or a related field.
- 2 years of relevant experience in regulatory affairs or a similar role.
- Advanced proficiency in Spanish and English (reading, writing, and speaking).
- Portuguese language skills are desirable.
- Experience in medical devices or pharmaceutical industry is preferred.
What We Offer
As a Regulatory Affairs Specialist at Medtronic, you can expect a competitive salary of $120,000 per year, flexible benefits package, and opportunities for growth and development. You'll be part of a global team that shares a passion for improving healthcare and making a difference in people's lives.
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