Regulatory Affairs Specialist

at  BD

JOB DESCRIPTION SUMMARY

The role involves creating, submitting, and maintaining product notifications for various BD portfolios in Czech Republic and Slovakia.

• Product Notifications: Create, submit, and maintain product notifications to support business operations.
• Document Review: Review and approve documents required for product notifications.
• Metrics Maintenance: Maintain monthly metrics related to product releases.
• Regulatory Tracking: Track EU and local regulations for medical devices and in vitro diagnostic devices in the region. Support Regulatory Intelligence team.
• Promotional Material Review: Review and approve advertising and promotional materials to ensure compliance with local and corporate requirements. Maintain trackers for reviewed and approved promotional materials.
• Documentation: Provide requested documents to customers and internal teams.
• Support Functions: Provide support to BD internal teams by responding to technical questions.
• Collaboration: Collaborate with regional RA teams to obtain strategic alignment for product launches and releases.
• Data Management: Input and maintain data, including licenses and registration records, in internal regulatory databases.
• Team Support: Support the EMEA Regulatory Affairs team, if needed.
• Regulatory Communication: Ensure timely responses to communications from Competent Authorities regarding regulatory issues.
• Reimbursement Activities: Manage reimbursement activities and ensure compliance with local regulations.