).Problem-solve and escalate regulatory and compliance issues to senior management as necessary.Drive continuous improvement in internal processes and customer satisfaction.Support the monitoring and interpretation of current and new regulatory requirements and international standards for the US and other regions.Ensure QMS requirements are followed and executed consistently from a Regulatory Affairs perspective.Support efforts for Technical File creation, remediation, and collaboration with cross-functional teams for required content.Support regulatory impact assessments for change controls and other Regulatory Affairs/Quality Assurance items from a review and approval level.Assist in preparing, auditing, editing, and publishing registration documentation as needed.Support business export control (BEC) listing of products for global release per Regulatory Affairs requirements.Review and approve labels, labeling, and promotional materials to ensure regulatory compliance.Work closely and collaboratively with Marketing and project teams to develop, review, and substantiate product claims.Assist in the collection of regulatory intelligence for projects related to US and international labeling remediation.Effectively communicate regulatory strategies to stakeholders.Perform gap analysis to support labeling projects and remediation activities.Remain current on standards and regulations affecting advertising, promotion, and labeling, and communicate the impact cross-functionally.Education• Bachelor's degree required with a focus in Life Sciences or Engineering preferred. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why Join Us?A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. At BD, you'll discover a culture in which you can learn, grow, and thrive. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.Salary Range Information PandoLogic.
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