Regulatory Affairs Specialist

Medtronic

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profile Job Location:

Johannesburg - South Africa

profile Monthly Salary: Not Disclosed
Posted on: 17 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

You are an administratively proficient person who despite routine also likes to interact across the globe to complete work being able to be part of a team that delivers on time sensitive projects. Your laptop is your companion and gateway to work.

The purpose of the job is to ensure regulatory compliance for the region of responsibility managing projects and assignments to ensure that Medtronic therapies are approved and compliance is maintained across all facets of premarket and post market surveillance and vigilance. The position is a hybrid (office and home) position based in Midrand Gauteng and while travel is minimal it cannot be discounted.


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.
  • 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 clinical trials applications.

Required Knowledge and Experience:

  • 4 years of experience in Regulatory Affairs area with advanced knowledge of job area combining breadth and depth. Knowledge of project management would be advantageous.
  • Bachelors Degree in a relevant field Bachelors Degree in Pharma is appreciated.
  • Ability to deal with multiple complex projects / issues simultaneously.
  • Strong MS office skills with SAP experience an advantage.
  • 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 LifeYou are an administratively proficient person...
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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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