Required Skills: Candidates who has worked in Regulatory Affairs in any Medical device companies. Candidates who has worked in Notified Bodies such as TUV, UL, BSI, SGS, Intertek etc with exposure to Medical device regulations. Relevant experience in Drug Safety case processing, drug safety database (e.g. ARISg or Argus), MedDRA and WHO-DRUG dictionaries Experience with performing quality checks on SAE reports, AE/SAE reconciliations.
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