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Sr Regulatory Affairs Specialist - Egypt, Libya, Sudan and Malta

Medtronic
Turlock, CA 95380
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Sr Regulatory Affairs Specialist - Egypt, Libya, Sudan and Malta

Location:

Festival City, Egypt

Requisition #:

2100015H

Post Date:

Jan 24, 2021


**Careers that Change Lives**


**A Day in the Life**

**SCOPE**


The candicate 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.


- Responible for vigilance submisions and follow up including Field Actions, Global Complaints handeling,..etc.


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


- Monitors and improves tracking / control systems.


- Keeps abreast of regulatory procedures and changes.


- 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 projectsfrom design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.


**DIFFERENTIATING FACTORS**


Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions.


Coaches and reviews the work of lower level specialists; may manage projects / processes.


Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.


Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.


Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.


Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others work product .


Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a Bachelor degree in Pharmaceutical Sciences,


4-6 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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
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.

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Posted: 2021-01-26 Expires: 2021-03-05
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Sr Regulatory Affairs Specialist - Egypt, Libya, Sudan and Malta

Medtronic
Turlock, CA 95380

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