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