Regulatory Affairs Specialist

at  Boston Scientific Corporation

REQUIREMENTS:

• Self-starter with 2 years’ experience in RA department
• Fluent written and spoken English (knowledge of Romanian would be an advantage)
• Applicable regulatory certification required by NAMMDR would be an advantage
• Ability to manage multiple projects and data and strong attention to detail
• Ability to communicate effectively to all levels of organization and distributors/consultants
• Very good knowledge of MS Office
• Bachelor’s or Master’s degree in pharmacy, biotechnology, chemistry or other related science or technical field

• Plan and prioritize product notification/registration for his/her respective countries (EU and non-EU)
• Prepare and submit regulatory applications to local health authorities and/or distributors
• Maintain active knowledge of product approval status and shepherd registrations throughout the approval process. Provide management team with regular updates on product registration
• Ensure product registrations are reviewed and renewed as required
• Ensure documentation used, questions and answers from authorities and approvals are appropriately filed
• Be the first contact point for local authorities for regulatory queries
• 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 through regular meetings, discussions, and/or trainings
• Establish relationships with local medical device industry groups and work with industry peers to influence local policies
• Serve as a regulatory consultant to marketing teams
• Complete the mandatory Quality training subject to the defined timeline and ensure compliance with internal Quality system and policy.