Regulatory Affairs Specialist

Duration: 12 Months

Responsibilities: 
 • Represents Regulatory Affairs on Post-Market RA Team for the Point-of-Care Business Area. 
 • Executes, manages and tracks all activities to support International Product Registrations to integrate newly acquired IVD medical devices for POC Business Area. 
 • Hosts recurring global communication activities (teleconferences etc.) with Country RA to ensure registration requirements are met. 
 • Interacts closely with multiple functions, including Manufacturing, R&D, Marketing, Logistics, Labeling etc. 
 • Completes the review of promotional material and device labeling for regulatory compliance. 
 Preferred Skills: 
 - Minimum five years experience in Regulatory Affairs, preferably with a global manufacturer of medical devices. 
 - Experience with managing and preparing International Regulatory Submissions (CE Mark Technical Dossiers), other Global Submission 510(k)s, Pre-Submissions, and other regulatory submissions). 
 - Strong attention to detail with strong organizational and technical writing skills. 
 - Must manage multiple projects simultaneously. 
 - Must have experience working on multidisciplinary teams in a fast-paced, dynamic environment. 
 - Must have experience reviewing product labeling, including advertising/promotional materials. 
 - Must have strong written and verbal communication skills. 
 - Must be well versed in QSR Design Control requirements and in educating project teams on these requirements. 
 Education: 
 - BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas

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