Senior Regulatory Operations Specialist (Remote)

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

Medtronic is among the largest medical technology companies in the world. Through innovation and collaboration, Medtronic helps to alleviate pain, restore health, and extend life. Last year, our medical therapies for the treatment of over 40 major conditions, improved the lives of more than 75 million people around the world.

The Senior Regulatory Operations Specialist will drive collaboration in interconnected processes; GTS strategy activation and implementation; support/lead transformational projects. This Role is Remote based in Colombia.

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

• Responsible for the preparation, publication, quality control, and delivery of paper and electronic components of all submissions including initial large marketing authorization applications and electronic common technical documents (e-CTD)
• Support activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs
• Ensure continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors
• Prepare, submit, track, index and archive paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials

Required Knowledge and Experience:

• Bachelor’s degree
• Five years of experience in regulatory affairs or related areas.
• Fluent in English
• Proficient in Microsoft Office (Outlook, Excel, Word, PowerPoint)
• Growth, and global mindset
• Ability to transform knowledge into solutions (automations / digitization)
• Experience with SAP and GTS 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.

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