Regulatory Affairs Intern - Boston Scientific

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.

Regulatory Affairs Intern – Boston Scientific

Duties and responsibilities to assist RA specialist in the below:

• Product Registrations

Ensures country/ district medical product approvals process and submissions when relevant, product notification and registration, if applicable, as per local countries requirement.

• Preparation of product registration documentation.
• Coordinates with distributors, Competent Authorities and/ or Authorized Representative for product registrations. 
• Tracks status of current and new product registrations.
• Releases registered products with the global team for shipment.

• Egypt and North Africa: Ensuring compliance with regulations in Egypt and North Africa.

• Communicate with distributors for follow-up on submissions under review. Or for any clarification on submission pathways or requirements.
• Communicate with customer services as needed.
• Product release: Working with supply chain and Customer Services for processing of legal status/ Source list for release of products before shipment
• Promotional material/Advertising: Review and approve product promotional materials, for compliance with applicable regulations and policies in Egypt.
• Change Notifications: Assess and determine the types of regulatory submissions or internal documentation that are required for any proposed device changes in Egypt and North Africa.
• Communicate regulatory changes affecting product change notifications to the manufacturer.
• Maintain all records in the local folder (Product approvals, dossiers, etc..)

Qualifications:

BSC degree (Health Science, Pharmacy, Microbiology, Biochemistry, Biomedical Engineering, pharmaceutical Engineering, Chemistry etc)

Other Relevant SKILLS Include:

Problem solving: Ability to quickly grasp the core of a problem and attend to relevant detail when analyzing a problem.

Flexibility: Ability to adapt work methods, ideas and habits to the changing environment.

Interpersonal Skills: Ability to display awareness and consideration for other people’s feelings, needs, viewpoints and opinions

Task structuring: Ability to plan, prioritize and structure own work to achieve objectives.

Technical skills: Ability to understand technical aspects of work

Team work: Ability to work as part of a team and contribute to the overall effectiveness of the team.

Attention to detail: Ability to identify and correct errors.

Communication: verbal and written

Computer skills: MS Word, MS Excel, Power Point, using email and the internet

Languages: Fluent in English, French is an add on.

Requisition ID: 629237

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.