Regulatory Affairs Specialist II

Regulatory Affairs Specialist IIDuration: 12 monthsThe Regulatory Affairs Specialist II will draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presented in a manner to facilitate review, and are in conformance with appropriate statutes, regulations, and guidelines.Key Responsibilities:The Regulatory Affairs Specialist II will join existing team and provide support for International Registration of IVD products.Tasks will include initiation, collection, and coordination of information of regulatory documents for various purposes.Preparation and maintenance of product technical files for CE markingOrganization and preparation of documents for international submissions, including drafting reports, and preparing documentation for submissionsCoordination with international counterparts to obtain product approvals and renewals.Maintaining logs and trackers.Organize, update, and maintain regulatory documentation in accordance with department and company procedures.Minimum Requirements:Bachelors degree in a scientific, engineering or related field is required2+ years of experience working in regulatory environment –RA/QA/R&D/QCWorking knowledge and experience with IVD productsKnowledgeable in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, IVDR and import/export requirementsStrong oral and written communication skillsAbout US Tech Solutions:US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.AI Statement:By applying, you acknowledge that AI-assisted tools may be used during hiring. IND01 #LI-AS140