Complaints And Compliance Manager- Medical Devices

Tosoh Group America South San Francisco , CA 94080

Posted 2 months ago

Tosoh Bioscience Inc., is a U.S. subsidiary of Tosoh Corporation's Bioscience Division, headquartered in Tokyo, Japan. Located in South San Francisco, CA, Tosoh Bioscience, Inc. is the leading provider of sophisticated medical diagnostic systems utilized by doctor's offices, hospitals, and reference laboratories throughout the United States. As the leader in clinical diagnostics, Tosoh's state-of the-art immunoassay analyzers and HPLC systems continue to meet the operational and economic needs of our customers. Tosoh remains at the forefront with a world class network of research facilities, scientists, engineers and customer support specialists. We have a solid commitment to provide Tosoh customers the best in clinical diagnostics.

SUMMARY:

Provide management support for Complaint and Compliance personnel. Oversee preparation and reporting of Medical Device Reports (MDR), Medical Device Vigilance (MDV), and US FDA and applicable international regulatory agencies. Interface with all departments to coordinate plans that will insure excellent service to Tosoh Bioscience, Inc. (TBI) customers. Ensure compliance with FDA and ISO requirements. This position is based in TBI's office located in South San Francisco, CA. Minimal travel may be required.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Provide management level decisions for Complaint and Compliance Specialists, Data Analysts and Complaint

  • Maintain a knowledge base of product specifications, performance characteristics, competitive differences, applications, clinical utility, as well as chemical and physiological effects on analysis of all TBI

  • Build levels of technical knowledge and expertise to serve as first line support to compliance

  • Promote open communications with all relevant department managers to proactively identify compliance needs and resolve complaint handling and escalation

  • Ensures complaint investigations and regulatory reporting decisions are completed in accordance with applicable regulatory requirements per country and TBI

  • Ensure MDRs I MDV s are submitted to applicable country regulatory authorities and meet regulatory requirements, including timely

  • Ensure proper compliance documentation in SLX/CRM database by monitoring TSG entries and trend reports.

  • Responsible for the preparation and evaluation of monthly trending

  • Participate in external and internal regulatory audits and regulatory processes as required for matters related to Complaints and Regulatory

  • Provide monthly reports for management that measure the effectiveness of the complaint specialist, data analyst and auditor

  • Identify training needs to provide expert knowledge base within the compliance

  • Monitor timely completion and I or submissions of complaint investigations and MDRs I

SUPERVISORY RESPONSIBILITIES:

  • Supervise minimum six direct

  • Hire complaint specialist, and data analyst and complaint auditor personnel as

  • Bachelor of Science in Biochemistry or Medical Technology; Master's

  • Excellent computer skills (MS Excel, MS Word, relevant statistical programs).

  • Minimum of 5 years Technical Support Hotline or Laboratory Supervisory/Management

  • Exceptional communication skills to interface with customers, employees,

  • Direct experience with any combination of Technical (Hotline) Support, Field Service, and/or

  • Knowledge ofTosoh diagnostic products a

  • Knowledge of 21 CFR 820, 803, and 806, ISO 13485, and international regulatory (Canada and Latin America)

WORKING CONDITIONS:

  • This position may require visits to customer sites which are medical These facilities may have certain requirements which TBI representatives must meet to gain access, including the requirement for drug, background, and health screening. Employment is contingent on your compliance with the requirements established by each facility, as evidenced by the results of the required screenings.

  • Must agree to provide required immunization records and/or agree to acquire required immunizations in order to gain access to customer sites as required by You may be required to register at vendor credentialing companies.

PHYSICAL AND ENVIRONMENTAL DEMANDS:

To perform this job successfully, the individual must be able to work on a computer for extended periods of time and perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and I or ability required to be successful. Additional duties may be assigned in the future as required. Reasonable accommodations may be made for those individuals with disabilities in order to perform the essential functions.

TOSOH BIOSCIENCE, INC. (San Francisco, CA) - is a leading supplier of sophisticated diagnostic systems supporting diagnostic technologies. Tosoh Bioscience Inc. is part of the Bioscience Division of Tosoh Corporation.

TBI, Inc. is an Equal Opportunity Employer M/F/Disabled/Veterans


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Complaints And Compliance Manager- Medical Devices

Tosoh Group America