Associate Regulatory Affairs Specialist

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**: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 exciting and rewarding place to be.
We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. This position will be remote in Colombia.

**Responsibilities may include the following and other duties may be assigned**:

- Compliance with Medtronic policies and relevant regulations, plans and organizes in a direct manner or performs coordination related to the preparation of document packages for regulatory submissions from regulatory affair processes
- Lead all materials required in submissions, license renewal and annual registrations, according to the plan requirements
- Interact with regulatory agencies on defined matters.
- Keep abreast of regulatory procedures and changes
- Follow timely the whole regulatory process, ensuring the fulfilment of each stage requirements. Maintaining updated the Medtronic tool (Excel, Smartsheet) designated to track regulatory processes advance
- Provide status on time about projects under their scope and all applicable regulatory activities assigned per Sr Supervisor or RA Manager
- Ensure regulatory efficiency by impacting their process from master dossier or information available from other projects

**Required Knowledge and Experience**:

- Bachelor’s degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering
- Fluent in English
- One year of relevant experience in regulatory affairs, customer service, technical support
- Knowledge working with MS Office
- Ability to work in matrix structured organization
- Regulatory affairs experience and knowledge with SAP and is advantageous

**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 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.