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Regulatory Affairs Specialist vacancy - North East Africa at medtronic

Regulatory Affairs Specialist vacancy - North East Africa at medtronic 



Festival City, Egypt

SCOPE

The candidate will be responsible  for North East Africa cluster including Egypt, Libya, Sudan and Malta.

 

LOCATION

The candidate will be based in Medtronic office in Cairo, Egypt

 

Job Description

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.

- Recommends changes for labeling, manufacturing and marketing for regulatory compliance.

- Monitors and improves tracking / control systems.

- Keeps abreast of regulatory procedures and changes.

- May direct interaction with regulatory agencies on defined matters.

 

CAREER STREAM

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

 

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger,

moderately complex projects / assignments.

 

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.

 

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

 

Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.

 

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

 

Required Knowledge and Experience:

 

Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a Bachelor degree in Pharmaceutical Sciences,

and minimum of 2 years of relevant experience.

 

REPORTING LINES

The candidate will be solid reporting to North East Africa (NEA) Regulatory Manager


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.


Additional Information

·        Posting Date: Nov 26, 2020

·        Travel: No


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