Integra LifeSciences Mansfield, MA, USA
Jul 08, 2018Full time
Job Description: Overview Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care. Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra's Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices. Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART." Responsibilities The CHU Specialist III will own the complaint handling process for their portion of the CSS business. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The CHU Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks; regulatory determinations and submissions required for complaint processing/closure. The CHU Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts to support overall post market processes, product launch and quality activities. * Own/lead CHU activities associated with complaint handling and regulatory submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting, complaint review and metrics for complaints received from customers and via literature. * Responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. * Directly interface with WW hospitals, surgeons, and internal employees for reporting of complaints and adverse events. * Execute decision trees; prepare and submit Medical Device Report (MDR) and/or Vigilance Report (MDVs). * Support service & repair events including evaluation of intake information and review of repair activities * Interact positively with customers, patients, internal/external business partners and colleagues. * Expedite investigations by collaborating with internal/external business partners. * Responsible for complaint determination and reportability assessments. * Track complaints in the process for closure independently * Participate in quality system activities and act as quality system task owner as required (NC, audit, CAPA) * Update and revise work instructions based upon self-identification of compliance gaps and process improvements in additional to directed updates * Initiate product replacement orders associated with complaints. * Prepare various reports on complaint trending, complaint metrics, post market surveillance activities, regulatory affairs activities, research and development activities, etc. * Support launch activities and stability metrics * Ability to mentor others, ability to be mentored by others Qualifications * A minimum of a Bachelors or equivalent degree with 5 years of experience or an Associate's degree with 8 years of experience is required * Experience working in a in a GMP or ISO environment is required, Medical Device or pharma experience is preferred * Experience in post market regulatory, quality or compliance areas is preferred. * Experience filing MDV and MDRs is required. * Strong knowledge of Microsoft Excel (v-lookups and pivot tables) is required. * Strong problem solving/Root cause analysis skills are required * Knowledge of basic medical terminology is required. * Ability to lead efforts aimed at the identification of problematic situations, reporting issues, and the development of resolutions and decision making is required. * Lean / six sigma training and/or certification is desirable * Knowledge of and familiarity with global regulations for reporting is required * This position is located in Mansfield, MA and will require up to 10% travel.