Regulatory Specialist Sr

Contract Role Regulatory Specialist SrRegulatory Specialist Sr for client at San Diego, CA.Location: San Diego, CA – 92121Project Duration: 6 Months of contractShift Timing: 9:00 AM to 5:00 PM (Mon to Fri)Pay Rate: $54.00 per hour on W2Responsibilities:Participates in some of the following: continuous improvement activities, product plan development and implementation, regulatory strategy, risk management, regulatory policy and intelligence.Ensures timely approval of new medical devices and continued approval of marketed products.Serves as regulatory representative to cross-functional teams.Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.Qualifications:Must have 7 years of experiences in Medical Device Regulatory AffairsConsidered as highly experienced with regulatory change assessments.Working knowledge in US Medical Device SubmissionsAbout generis tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients' specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.