Regulatory Affairs Specialist, Egypt

Additional Locations:  N/A

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At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Regulatory Affairs Specialist, Egypt

As a Regulatory Affairs Specialist, you will be responsible of supporting the regulatory submission and provide input on regulatory-related issues associated with compliance and achieving the business plan for Egypt& African countries as needed.

Key Responsibilities:

• Prioritize and plan on product registration for his/her respective product lines.
• Preparing, coordinating, and submitting regulatory applications dossiers in coordination with business partners registration, Vigilance,  ..etc.
• Maintain an active knowledge of the status of pending approvals /submissions, and shepherd registrations through the approval process. 
• Provide the management team with regular updates on product registration.
• Ensure product registrations files are reviewed and renewed as required.
• Supports tender operations by timely supply of accurate regulatory documents.
• Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
• Complete the mandatory Quality training subject to the defined timeline.  And ensure compliance with internal Quality system and policy.
• Ensures to meet additional Regulatory project requirements support if assigned and when needed.
• Attend team meetings as required.

Required Skills and Qualifications:

• Bachelors Degree in Scientific discipline/engineering preferred
• Has the at least 3 to 5 years’ experience in Regulatory environment
• Knowledge and experience of local regulations and standards.
• Knowledge and experience with the Egyptian Authority different departments.
• Must highly have organization skills / and can manage multitask in very competitive environment. 

Requisition ID: 632701

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.