Sr. Regulatory Affairs Specialist

Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. Job responsibilities:Develop and execute international regulatory strategy for the successful registration of in vitro diagnostic (IVD) devices in markets outside of US and EU. Negotiate and establish product submission priorities that are aligned with IVDR priorities and region/country needs.Understands and interprets EU and international in vitro diagnostic (IVD) device regulatory requirements.Generate, coordinate, and manage regulatory submission documents for new products, renewals, or changes to existing products; ensure compliance with global regulations and guidelines. Coordinate responses to regulatory agencies as part of the submission and approval process.Represent RA in cross-functional product development teams to provide guidance on global regulatory strategies.Support change management by evaluating design, manufacturing and process changes for regulatory impact globally.Review Analytical and Clinical protocols to assure collection of appropriate data for regulatory submissions. Review/ Approve labels, labeling, and promotional materials for compliance with applicable regulations and policies. Develop and maintain procedures and/or work instructions for product registrations.Provide regulatory support during internal and external audits.Submit and maintain laser registrations for all instruments (IVD and RUO) when needed.Manage, monitor and track International product registration in Regulatory Information Management (RIM) database to ensure up to date information.Additional activities as needed to support RA goals.