Vacancy caducado!
DescriptionPosition Summary:The Regulatory Affairs (RA) Lead Engineer is responsible for the regulatory strategy for the Front Line Care portfolio including vision care and physical exam devices which includes software and SaMD. This position supports new and sustaining product development teams.The Lead RA Engineer will identify applicable performance and safety standards and will assist product development teams in the creation and maintenance of technical documentation, providing a basis for successful product registrations globally. Effective collaboration with regional RA colleagues and OUS/CA registration peers is essential.Directly responsible for US and Canadian licensing.Essential Duties:Provide global performance and safety requirements as an input to product design teams
Manage registration plans through collaboration with global RA peers
Direct safety agency test planning and execution
Review scientific/engineering materials (protocols/reports)
Review and approve test compliance reports and associated technical documentation
Review product labeling including advertising and promotional material for compliance
Prepare pre-subs, IDE’s and pre-market clearance applications for USA
Prepare license applications and technical documentation for Canada
Support OUS/CA product registration teams
Provide regulatory assessment on proposed changes to marketed devices
Facilitate communication and tracking of changes to regulations and standards by maintaining a library of information
Support continuous improvement activities
Fulfill other requests as needed by the business
#INDHRQualificationsBachelor's degree - preferably in Engineering or a related Science
Masters RA/QA is strongly preferred
Minimum 5 years’ experience in RA and/or product development in medical devices
Experience with FDA submissions strongly preferred
Experience with SAP ECC6/EHP7 strongly preferred
Experience with vision devices, medical software, or AI algorithms is desirable
Strong project planning, leadership, negotiation and presentation skills
Proven ability to contribute creative yet practical solutions to problems
Strong cross-organizational collaboration with internal teams and external agencies
Job: RegulatoryPrimary Location: United States-New York-Skaneateles FallsOther Locations: United States-Oregon-Portland, United States-Illinois-Chicago, IL, United States-Minnesota-St. Paul, United States-Wisconsin-Milwaukee, United States-Illinois-Chicago - Home Office/VirtualSchedule Full-timeTravel Yes, 10 % of the TimePosting Entity Welch AllynReq ID: 20124013
Vacancy caducado!