Regulatory Affairs Specialist, Medical Device Contract Katalyst Healthcares & Life Sciences is hiring entry-level candidates for several positions for contract research in clinical trials of drugs, biologics, and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with university hospitals, pharmaceutical companies, and recruiting partners. Requirements & Responsibilities: Compilation of DHF and Technical Files. Handling the regulatory assignments with a good understanding of medical process standards ISO13485, ISO14971, IEC 62304, and IEC 62366. Thorough understanding and application of USFDA regulations. Thorough understanding and application of EUMDD regulations. Ensuring Quality Assurance as per defined process. Participating in Design Review Meetings. Regulatory strategy preparation. Regulatory assessment for the Electro-mechanical devices. Regulatory review of Technical documents. Regulatory submission for various countries. All your information will be kept confidential according to EEO guidelines. #J-18808-Ljbffr Katalyst Healthcares & Life Sciences
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