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Regulatory Affairs Specialist
hace 1 día
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.
**A Day in the Life**:
**Responsibilities may include the following and other duties may be assigned**:.
- 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.- Verify and validate the information to be published in the databases.- Active participation on SSC projects
**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.
**Benefits & Compensation**:
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic **:**We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.**
**Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.**
**We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
