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- Company Name:
- GRN Utica
Job SummaryThis position supports domestic and international regulatory compliance for products produced and/or distributed by the Company.. Duties & Essential Job Functions:Preparation of domestic and international regulatory submissions and creation and maintenance of technical files Supports new product development and design changes by participating in FMEA activity, Labeling Reviews and Design Reviews as assignedPerforms internal audits and supports audits by 3rd parties (TUV, FDA) as requiredPerforms regulatory review of Marketing and Engineering materials in New Product Release, Product Labeling and Market Release activities Regulatory review of ECN's as requiredOther responsibilities as required and/or assignedExperience/Skills Required:2-3 years minimum work experience in FDA-regulated industry Working knowledge of domestic and international Medical Device Regulations510(k) experience. IDE/PMA a plusMicrosoft skills (Excel, Word, Access) Internal auditing experience Required Education / Licensing/ Certification:B.S. or B.A. degree CQA, RAC or RAB a plusEmail resume to Camley Hitti at