New job Now hiring Regulatory Reporting Specialists in San Antonio, TX.

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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: Now hiring Regulatory Reporting Specialists in San Antonio, TX. Daniel Perry posted a job: Now hiring Regulatory Reporting Specialists in San Antonio, TX. "Job: Regulatory Reporting Specialist in San Antonio, TX To apply:  If you are interested in applying for this position, please visit BD at http://www.bd.com/careers/ and select by key word REG0004Q.  Genral Function: Under the direction of the Manager, Customer Management Center, manages activities and procedures associated with complaints concerning BD MS, DC, PAS products. Accountable for setting own work direction and completing work tasks. Supervise the processing of customer complaints, Medical Device Reports (MDR), including maintenance of complaint files, responses to customers and complaint reports. Responsibilities: Develop, implement and follow procedures to ensure timely and accurate receipt, logging, analysis and response to customer complaints. Reviews all Customer complaints for validity and assures complaints are processed in compliance with policies and procedures. Provide guidance, final review and approval of generated MDR reports in accordance with BD procedures and FDA regulations. Contribute to the business-wide quality strategy and quality objectives Maintain systems to monitor and facilitate the timely investigations and close out of open complaints. Ensure complaints are investigated and completed in a timely manner. Monitor and communicate significant complaint trends, adverse events and other pertinent reports Provide internal awareness of noted trends and complaint issues via periodic and ad hoc reports as required by the business unit/platform team. Interact with Health Care Workers, Consumers and other professionals regarding their Product Quality concerns. Assist in maintaining customer relations via teleconferences, written correspondence, on-site visits, conventions and meetings. Ensure the customer complaint investigation, procedures, and activities comply with applicable FDA and ISO requirements for complaint handling and adverse event reporting. Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary Ensure ethical responsibility to maintain privacy and confidentiality of patient records and private information.     Required Experience: Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, and ISO 13485 / 14971 Two (2) year or more experience in the complaint handling, Medical Device industry, Customer relations, complaint trending, MDR submissions, FDA regulations, GMP and where applicable clinical and other laboratory functions. Product knowledge – must have working knowledge of product usage & be able to differentiate between significant and non-significant health risks (to either the patient or health care worker) Must have knowledge of product failure modes Experience in health care setting desirable, e.g. clinical labs, hospitals, doctor’s offices, health care delivery settings. Skills: Strong analytical, deductive reasoning and listening skills High level of problem identification, analysis, and fo... http://bull.hn/l/QFHO/2"

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