Regulatory Affairs
Specialist vacancy - North East Africa at
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
APPLY HERE