Documentation Specialist

Regulatory Affairs Specialist IIVARITE is looking for qualified Regulatory Affairs Specialist II in Fremont, CA 94538 (Onsite). An American-headquartered life science and clinical research company. It is a global supplier of analytical instruments, clinical development solutions, specialty diagnostics, laboratory, pharmaceutical and biotechnology services. Established in the Year 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850+ global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.Job Title: Regulatory Affairs Specialist IILocation: Fremont, CA 94538 (Onsite)Contract Duration: 12 months with possible extension. Pay Rate Range: $30.00 - $33.00/hr. on W2.Position SummaryThe 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 skillsBENEFITS: We offer a comprehensive benefits package designed to support the health, well-being, and financial security of our employees and their families. Eligible employees may receive:Health Insurance: Medical, dental, and vision coverageRetirement Plans: Participation in a company-sponsored retirement savings plan.Legal Service Plans: Offering access to attorneys for legal advice and representation.VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Varite