Sr. Regulatory Affairs Specialist

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.

Education and Experience: Bachelor's degree required, strongly preferred in the biological sciences, chemistry or related science. Minimum 3 years' experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs. Tech file preparation and approval experience a plus. Ideal candidate will have demonstrated ability to interpret new regulations, and understand and interpret in vitro diagnostic device (IVD) regulatory requirements. Current knowledge of in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP) and Quality System Regulations (QSR); and European quality system standards. Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization. Strong Project Management experience desirable, ability to prioritize, multi task, and organize work.