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- Company Name:
- GRN Utica
Sr. Regulatory SpecialistJob 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 assigned?Performs internal audits and supports audits by 3rd parties (TUV, FDA) as required?Performs regulatory review of Marketing and Engineering materials in New Product Release, Product Labeling and Market Release activities ?Regulatory review of ECN?s as required?Other responsibilities as required and/or assignedExperience/Skills Required:?5-7 years work experience in FDA-regulated industry ?Working knowledge of domestic and international Medical Device Regulations?Experience in Orthopedics or Spine industry preferred?510(k) experience required. Previous experience with IDE/PMA/annual reporting preferred.?Microsoft skills (Excel, Word, Access) ?Internal auditing experience Required Education / Licensing/ Certification:?B.S. or B.A. degree ?RAC?CQA, or RAB a plus