Regulatory Affairs Specialist

Medtronic

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profile Job Location:

Johannesburg - South Africa

profile Monthly Salary: Not Disclosed
Posted on: 30+ days ago
Vacancies: 1 Vacancy
The job posting is outdated and position may be filled

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


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:
Bachelors 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 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 LifeIn this vital role you will be responsible fo...
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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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