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QA RA Specialist

Company: Katalyst Healthcares & Life Sciences
Location: Baltimore
Posted on: April 10, 2021

Job Description:

--- 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. Job Description Job Description: --- Quality and Regulatory Affairs Engineer with extensive experience in Medical Product development process - Electromechanical Devices. Responsibilities: --- Compilation of DHF and Technical Files.--- Handling the regulatory assignments with 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--- Minimum 5 years' experience in QA for Medical Device company Additional Information All your information will be kept confidential according to EEO guidelines. Other jobs at Katalyst Healthcares & Life Sciences

Keywords: Katalyst Healthcares & Life Sciences, Baltimore , QA RA Specialist, Other , Baltimore, Maryland

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