Regulatory Affairs Specialist - Egypt At BD
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.