Senior Regulatory Affairs Specialist

Additional Locations:  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

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.

Purpose

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 2 to 3 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: 590838

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!