Regulatory Affairs Specialist - Egypt

؜ - ؜القاهرة ؜ -

تفاصيل الوظيفة

Job Description Summary


Job Description


Be part of something bigger!
BD is one of the largest global medical technology companies in the world and
is advancing the world of health by improving medical discovery, diagnostics
and the delivery of care. We have over ‎65,000 employees and a presence in
virtually every country around the world to address some of the most
challenging global health issues.
Launching of Medical Device & In-Vitro Diagnostic Products in the Egyptian
Market in addition to facilitating the importation of shipments and ensuring
the absence of any regulatory issue in alignment with company standards and
country regulations.
Other Key Responsibilities :-
* Submission of registration for key launches for medical devices (MDs) and in-vitro diagnostics (IVDs) as well as following up closely until license issuance
* Managing regulatory lifecycle product management through re-registration, renewal, and variation Submission on time as required.
* Clearance support to distributors by providing all required documentation for importation.
* Updating RIM, tracking sheets, and monthly reports to reflect work in progress in an organized fashion.
* Responding to Notifications of Change (NOCs) & Impact Assessments (IAs) with clear responses on time.
* Tender support to commercial teams & distributors.
* Providing regular support, feedback, status updates and coordination related to Egypt for all Business Units to related internal and external stakeholders.
* Coordinating Post Market Surveillance activities, such as FSCA/FSN/recalls notifications and following up with MD Vigilance Department where applicable
* Working closely with regulatory affairs internal affiliates to capture the existing and upcoming regulatory expectations and take appropriate actions.
* Managing storage facility and tracking of samples as per the local guidelines
* Having a solid communication with the Egyptian Drug Authority regulators while having a deep understanding of the local regulations, guidelines, and processes.
* Developing a close partnership with local business and distributors for coordinating regulatory activities with their teams
* Close & efficient follow up with EDA reviewers.
About You :-
* Bachelor 's (B.Sc.) Degree of Pharmaceutical Sciences
* ‎2-‎3 years in the Medical Devices Sector
* Proficiency in spoken and written English and Arabic.
* Attention to details.
* Excellent communication and presentation skills.
* Successful history of prioritising multiple projects and prioritizing/scheduling activities and managing tight deadlines
* Craft the current processes of having the work done in an innovative way that better supports the business.
* Great teammate
Why join us?
A career at BD means that you are part of a team that values your opinions and
contributions and that empowers you to bring your authentic self to work. Here
you can fulfill your life 's purpose through the work that you do every day.
You will learn and work alongside inspirational leaders and colleagues who are
equally passionate and committed to fostering an inclusive, growth-centered,
and rewarding culture. Our Total Rewards program -- which includes competitive
pay, benefits, continuous learning, recognition, career growth, and life
balance components -- is designed to support the varying needs of our diverse
and global associates.
Becton, Dickinson and Company is an Equal Opportunity Employer. We do not
unlawfully discriminate on the basis of race, color, religion, age, sex,
creed, national origin, ancestry, citizenship status, marital or domestic or
civil union status, familial status, affectional or sexual orientation, gender
identity or expression, genetics, disability, or any other protected status.
To learn more about BD visit https://emea.jobs.bd.com/


Primary Work Location


EGY EGYPT - Field Only

ملخص الوظيفة

  • المُعلن : BD
  • تاريخ الإعلان : 11/09/2021
  • نوع العمل : -
  • مستوى الخبرة : -
  • المستوى التعليمي : -
  • مكان العمل : القاهرة
  • الراتب : -
  • الهاتف : -

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