Location:

Nairobi, Nairobi, Kenya

Requisition #:

18000ESA

Post Date:

Dec 19, 2018

Careers that Change Lives

PURPOSE OF JOB:

The main purpose of the job is to provide regulatory support, be responsible for activities that lead to and maintain regulatory approvals/compliance of medical devices with various regulatory agencies in the Sub Saharan Africa countries .

MAIN JOB DUTIES/RESPONSIBILITIES:

•Responsible for pre and post market regulatory functions for the Sub Sahara Region

•Prepare submissions, both for new products and product changes, as required to ensure timely approval/clearance for market release.

•Provide regulatory support to currently marketed products, as necessary.

•Maintain regulatory affairs product files to support compliance with regulatory requirements.

•Assists in the development of the regulatory strategy for the respective business unit(s)

•Works with Business Units to ensure prioritization of therapies and products and timely regulation of products entering the market

•Works with Strategic Business Units to ensure transparency, strategic alignment and availability of deliverables

•Supports product distribution release processes and geography launch/maintenance requirements

•Works with Regional RA specialists on all regulatory matters

•Provide on-going support to various stakeholders /teams on all regulatory issues and questions.

•Communicates and interfaces primarily with internal contacts. Infrequent outside customer communication on routine matters. May communicate with regulatory agencies in conjunction with line manager.

•Develops solutions to a variety of technical problems of moderate scope and complexity. Participates in planning and recommends solutions in problem solving discussions

JOB QUALIFICATIONS:

•Minimum Bachelor of Pharmacy degree.

•Solid organizational skills, flexible and adaptable to changing priorities. Innovative.

•Ability to establish objectives and achieve results.

•Experience with Project Management and ability to adhere to time schedules

•Effective communications to all levels of the organisation and customers (strong written and verbal skills)

•Self-motivated strong work ethic

•Ability to work co-operatively in a matrix environment and excellent interpersonal skills

•Strong attention to details

•Capability to establish and use networks to acquire information

• Results Orientation/History of successful regulatory submissions and approvals

•Experience with Project Management

JOB EXPERIENCE:

•Minimum 4-6 years’ experience in regulatory affairs and medical devices

•Knowledge of and dealings with regulatory authorities in the SSA region

SKILLS/COMPETENCIES:

•Honest and ethical

•Integrity

•Interpersonal Effectiveness

•Quality Orientation

•Continuous Learning

•Innovation

•Must be computer literate at an entry level:

• MS Windows
• MS Word
• MS Excel
• MS PowerPoint
• MS Outlook

•Lateral thinker and solution orientated

•Good interpersonal skills

•Motivation, drive, commitment

•Flexible

•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

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.

We want to accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The preceding job description has been designed to describe the general nature and level of work being performed by employees assigned to this position.It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities required qualifications and skills of this position.

The physical demands described within the 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.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.