Regulatory Affairs Specialist I

Job DescriptionFront Line Care (FLC) is a business unit of company focusing on medical devices that enable earlier diagnosis and treatment. The sooner the diagnosis-the more options for effective treatments. Our smart screening devices and diagnostic tools empower clinicians and health systems to identify and treat every patient with confidence, shortening the path to assessment and then to care. The FLC portfolio includes products for vision screening & diagnostics which focus on preventing blindness by facilitating early detection and treatment; physical exam & diagnostic tools; diagnostic cardiology connected electrocardiograph products; and respiratory care devices.The Regulatory Affairs (RA) Specialist is responsible to build and deliver on regulatory strategies andtechnical documentation to support regulatory submissions in LA, EMEA and EU for Front Line Caremedical devices. This individual will collaborate closely with other regulatory experts in these markets orother regulatory experts in other markets to achieve the best possible outcomes for effective productregistration. This individual is responsible for a broad range of products in the Front Line Care portfolio.The RA Specialist supports Global expansion, new and sustaining product development teams, and willwork closely with cross functional team members to assist with regulatory issues related to such items as global expansion strategy, registration, labeling, marketing claims and testing requirements. The RASpecialist is an individual contributor and reports directly to the Manager of Global Regulatory Affairs..Essential Duties & Responsibilities• Plan, coordinate and prepare regulatory documents in support of market expansion efforts• Liaison with ASEANNA office for establishing priorities• Prepare and collate product specific exhibits, artifacts for ASEANNA colleagues• Provide product labeling including advertising and promotional materials for registrations• Provide complex safety and performance test reports & associated technical documentation• Provide regulatory assessment on proposed changes to marketed devices• Support international product registration regulatory colleaguesEducation, Experience and Qualifications:• Bachelor's degree is required. Engineering, biology, or science related field preferred.• Minimum 1-3 years' experience in regulatory affairs. Advanced degree may be considered aspartial fulfillment of experience.• Experience with successful preparation of global registration• Proven ability to contribute creative yet practical solutions to problems• Strong cross-organizational collaboration with internal stakeholders and external regulatoryagencies