sr. quality systems and regulatory compliance specialist

  Regulatory Affairs

Job title: sr. quality systems and regulatory compliance specialist

Company: Randstad

Job description: job description sr. quality systems and regulatory compliance specialist in gurgaon JOB DESCRIPTION POSITION SUMMARY: Responsible for general support and maintenance of the Quality System/Regulatory Compliance within the requirements of the internati

job description sr. quality systems and regulatory compliance specialist in gurgaon JOB DESCRIPTION POSITION SUMMARY: Responsible for general support and maintenance of the Quality System/Regulatory Compliance within the requirements of the international and national standards such as the QSR, ISO 13485, 98/79/CE Directive for IVD including the document control system, corrective and preventive action system, internal audits and administrative support Material quality assurance, batch record issuance, management of the quality documentation. Field Safety Corrective Action and Reporting the Adverse Events Report to the competent authorities. Ensure compliance as per MDR 2017, European regulations, ISO 9001, ISO 13485.MINIMUM REQUIREMENTS: Education and Experience: Master’s degree in science (Biochemistry, Biotechnology, Pharmacy), medical or technical field 4-8 years of experience in the medical devices industry (IVD can be a plus) Knowledge and skills: Excellent verbal and written communication skills Knowledge of International Organization for Standardization ISO13485 Knowledge of International regulations QSR for USA, CE Directive and Regulation for India. Excellent planning and organizing skill Exceptionally strong team player with excellent interpersonal and communication skills Able to confidently deal with ambiguous issues and provide input towards suitable actions. PREFERRED REQUIREMENTS: Experience working with medical device quality systems in compliance with MDR and ISO 13485 Able to interpret quality problem and establish practical solutions within a dynamic business environment. Experience in leading continuous improvement efforts, in both quality systems and products. Knowledge of the process of establishing facility QMS certifications. Cross functional experience with products and commercial operations processes to influence change at all levels within the organizationVisio and Project knowledge desirable. skills QMS, Regulatory affairs, compliance qualification Any

Expected salary:

Location: Gurgaon, Haryana

Job date: Thu, 02 Sep 2021 22:36:47 GMT

Apply for the job now!

LEAVE A COMMENT