Regulatory Affairs Specialist Argentina

Medtronic

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profile Job Location:

Buenos Aires - Argentina

profile Monthly Salary: Not Disclosed
Posted on: 21 hours ago
Vacancies: 1 Vacancy

Job Summary

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

A Day in the Life

Were 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. Well support you with the training mentorship guidance and networks you need to advance and empower you to work in the way thats 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:

  • Bachelors 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 & 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.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

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 95000 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.

Learn more about our business mission and our commitment to diversity here


Required Experience:

IC

At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.A Day in the LifeWere a mission-driven leader in medical techn...

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

A Day in the Life

Were 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. Well support you with the training mentorship guidance and networks you need to advance and empower you to work in the way thats 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:

  • Bachelors 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 & 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.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

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 95000 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.

Learn more about our business mission and our commitment to diversity here


Required Experience:

IC

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About Company

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About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more

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