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

In this vital role, you will be responsible for executing regulatory activities in compliance with Medtronic standards and national regulatory requirements across the Southern Africa countries. You will be accountable for driving regional regulatory compliance by managing projects and assignments to support the approval of Medtronic therapies and the maintenance of compliance across all aspects of pre market and post market surveillance and vigilance. The position is a hybrid (office and home) position based in Midrand, Gauteng.

Responsibilities may include the following and other duties may be assigned:
•    Collaborate with global and regional teams to develop and execute submission plans aligned with business priorities
•    Prepare and quality check documentation packages required for registrations and listing activities
•    Support regulatory requirements needed for importation activities and tender submissions
•    Oversee the execution of post marketing activities including Field Safety Corrective Actions (FSCAs) and vigilance reporting in collaboration with global teams
•    Maintain effective communication and ongoing follow up with external agencies and different stakeholders
•    Keeps abreast of regulatory procedures and changes affecting business and proactively communicate updates to relevant stakeholders
•    Monitors and improves internal tracking / control systems

 
Required Knowledge and Experience:
•    Bachelor’s degree in Medicine, Pharmacy, Bioengineering, Chemistry or related field
•    4+ years of experience in Regulatory Affairs preferably in medical devices field
•    Fluent English both spoken and written
•    Advanced Microsoft Office skills
•    Good organizational skills
•    Good communication skills
•    Self-motivated, proactive & dynamic
•    Ability to deal with multiple complex projects / issues simultaneously
•    Strong Integrity and ethical values
•    Team player
 

 

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 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.

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