Regulatory Affairs Specialist at Medtronic

Main Purpose of the Job:

As a Regulatory Affairs Specialist you will compile and submit dossiers for submission to the regulatory authorities in Sub Saharan Africa countries that are regulated for medical devices. You will work within a team of specialists and gain a vast and in depth knowledge of the different Medtronic medical devices.

A Day in the Life:

• You will be responsible for pre and post market regulatory functions for the Sub Sahara Region
• You will prepare submissions, both for new products and product changes, as required to ensure timely approval/clearance for market release.
  You will provide support to currently marketed products, as necessary.
• Maintain regulatory affairs product files to support compliance with regulatory requirements.
• You will assist in the development of the regulatory strategy
• Work with Business Units to ensure prioritization of therapies and products and timely regulation of products entering the market
• Work with Strategic Business Units to ensure transparency, strategic alignment and availability of deliverables
• Work with Regional RA specialists on all regulatory matters
• You will provide on-going support to teams for regulatory issues and questions.
• Communicate and interface primarily with internal contacts. Infrequent outside customer communication on routine matters. You may communicate with regulatory agencies in conjunction with line manager.
• You will develops solutions to a variety of technical problems of moderate scope and complexity. Participates in planning and recommends solutions in problem solving discussions