Junior RA Specialist Job

There's never been a better time to be a part of Boston Scientific. This is an exciting moment: when our legacy of industry leadership intersects with the promise of a brilliant future. Today, we're 32,000 colleagues strong, with an impressive portfolio of 13,000 products. We’re at the forefront of the medical device industry – leading, evolving and transforming it into bolder and more amazing territories. Our principles power our performance, and together, we turn our shared vision into value.
For our patients and our employees.

Workplace: Bucarest , Romania

Junior Regulatory Affairs Specialist

Principal responsibilities:

• Plan and prioritize product registration and/or notification for his/her respective countries
• Prepare and submit regulatory applications to local health authorities and/or distributors
• Maintain active knowledge of product approval/notification status and shepherd registrations throughout the approval process. Provide management team with regular updates on product registration
• Ensure product registrations/notifications are reviewed and renewed as required
• Ensure documentation used, questions and answers from authorities and approvals are appropriately filled.
• Be the first contact point for local authorities for regulatory queries
• Support tender operations by timely supply of accurate regulatory documents
• Serve as regulatory consultant to marketing teams
• Establish and maintain a good working relationship with regional and divisional RA peers to gain positive and timely support for submission preparation
• Establish and maintain a trusted relationship with local health authorities and/or distributors
• Establish relationships with local medical device industry groups and work with industry peers to influence local policies

Requirements:

• Fluent written and spoken English
• Knowledge of any of the following languages would be an advantage: Greek, Czech, Romanian, Russian
• Strong attention to detail
• Ability to manage multiple projects and data
• Ability to communicate effectively to all levels of organization and distributors/consultants
• Ability to work in a team
• Self-starter
• Very good knowledge of MS Office
• Bachelor’s or Master's degree in pharmacy, biotechnology, chemistry or other related science or technical field

We offer:

• Work in an international environment in a successful company with excellent market position
• Valuable Package of benefits
• Possibility to grow and develop your career
• Attractive employment conditions

If you are interested in this position and meet the requirements, please apply, enclosing your CV
in English

BSC