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Regulatory Affairs Specialist
hace 2 semanas
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 LifeWe're a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.
Come strengthen your specialized skills and enhance your expertise. We'll support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that's best for you. Together, we can confront the challenges that will change the face of healthcare. Join us for a career that changes lives. The position will be located at Argentina in a hybrid model.
Responsibilities may include the following and other duties may be assigned:
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of 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 applications
Required Knowledge and Experience:
- Bachelor's degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or field related experience
- Fluent in English
- 2 years of relevant experience in Regulatory affairs experience in medical devices or pharmaceutical industry
- Ability to work in matrix structured organization.
- Experience using/working with the Office suite (Excel, PowerPoint, and Word)
- Would be an advantage having experience working with the Department of Health and understanding of market and laws for medical devices in Latin-American countries
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 & CompensationMedtronic 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.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
About MedtronicWe 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 95,000+ 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.
