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Associate Regulatory Affairs Specialist, APS

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Regulatory Affairs
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190002Q7 Requisition #
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Main Purpose of Job:


As an Associate Regulatory Affairs Specialist you will work as part of the APS RA team to prepare submission dossiers, track and follow up on regulatory submissions to competent authorities to ensure that our company and our products are complying with the local medical devices regulations in Saudi Arabia and Gulf States. You will also be coordinating meetings with our local marketing team as well as local distributors to ensure alignment on registration needs for our products. As a result we will be able to place our products in the market and also remain in compliance with the local law.

 

Duties:


        Support on filling submission dossiers

        Provide distributors with the supporting documents for shipment clearance.

        Establish and update trackers with ongoing submission projects, track progress and create reports.

        Maintain trackers of regulatory licenses and create progress reports.

        Work closely with RA team to follow up on ongoing submission projects.

        Create financial forecasts of regulatory submissions.

        Plan and coordinate periodic meetings between the RA team and different stakeholders.

Must Have: Minimum Requirements

 Familiar with regulatory submissions.

 Previous experience in administration.

 Fluency in both written and spoken English and Arabic

 Excellent software skills especially office programs

 Excellent written and verbal communication skills


About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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. 


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Change Begins With You

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Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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