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Sr. Regulatory Affairs Specialist- Maghreb Countries

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Regulatory Affairs
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19000JO5 Requisition #

SENIOR REGULATORY AFFAIRS SPECIALIST

North Africa Region (NA)

 

SCOPE

The candicate will be responsible for regulatory activities in North Africa cluster including Algeria, Morocco and Tunisia.

 

 

LOCATION

The candidate will be based in Medtronic office in Casablanca, Morocco.

 

 

JOB DESRIPTION

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, annual registrations and importation.

- 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 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 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 with at least

4 years of relevant experience

 

 

REPORTING LINES

The candidate will be solid reporting to Emerging Africa Regulatory Affairs Senior 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.

 

Founded in 1949 as a medical repair company, we're now among the world's largest medical technology, services and solutions companies, employing more than 89,000 people worldwide, serving physicians, hospitals and patients in over 155 countries. With our European Operations Center for Distribution and Shared Services in Heerlen, the Bakken Research Center in Maastricht, our manufacturing facility in Kerkrade, and the Dutch sales office in Eindhoven, Medtronic Netherlands has more than 1,750 employees. 

Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.


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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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