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
Must Have-  Minimum Requirements:
Tertiary Education with a life sciences degree, preferably B.Sc.
Minimum 1 years’ experience in regulatory affairs with medical devices
Knowledge of and dealings with regulatory authorities in the region
Must be computer literate
English language skills
Must be willing to work after hours when required.
 Must be able to work under pressure
Travel Required:
Travel to African countries may be required
Your Answer
Is this the position you were waiting for? Then please apply directly via the apply button!
PHYSICAL REQUIREMENTS:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.

Apply via :

ic.com