Senior Director, Customer Excellence

Details: Company Description Integra LifeSciences, a world leader in medical devices, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedics, neurosurgery, spine, reconstructive and general surgery.Integra's orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, tendon and peripheral nerve protection and repair, and wound 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 is also 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 3,000 employees worldwide. For the last three years, Integra has been included in NJBIZ's list of "New Jersey's 50 Fastest Growing Companies." In 2010, we were also included in Forbes magazine's "America's 100 Best Small Companies".We value innovative thinkers who are open to new opportunities and derive satisfaction from knowing that their efforts are making a difference in someone’s life.Detailed Description Areas of responsibility for this position include the corporate Complaint Management System, MDR and Vigilance Reporting, Health Hazard Evaluation System, Field Action / Product Recall oversight and Risk Management System.The position is responsible for ensuring that the Companies of Integra LifeSciences are in conformance with national and international regulatory statutes, directives and governmental quality system regulations. Corporate policies and company compliance must meet the requirements of the Food and Drug Administration, International Standards of ISO 9001, ISO 13485:2003, the Medical Device Directive, the Canadian Medical Device Regulations and all other applicable regulatory agencies. The position has oversight responsibility for the corporate Complaint Management System. Reporting to the Sr. Director is the Sr. Manager of Complaint Systems. Key responsibilities include monitoring, tracking, trending customer complaints, ensuring timely customer resolution and MDR/Vigilance reporting for all companies of Integra LifeSciences worldwide. Position has oversight responsibility for the corporate Risk Management System. Reporting to the Sr. Director is the Director of RA Compliance. Key responsibilities include review and approval of the Health Hazard Evaluation and Field Corrective Action Regulatory Strategy. Position has oversight responsibility for the execution of the Field Corrective Action Regulatory Action Plan including contacting regulatory authorities and measuring field action effectiveness. Provide analysis and timely reporting of key compliance trends and issues regarding customer complaints and product quality field actions and corrective actions at each Division and Company. Integrate company acquisitions as appropriate to the Integra LifeSciences Corporate Compliance System and ensure they are in compliance with appropriate regulatory statutes, regulations, and directives. Establish Corporate Policies and procedures across all Integra LifeSciences corporate, division and facilities to align compliance processes. Maintain up to date understanding of all issues and changes in regulatory compliance activities at FDA, European Economic Area, Japan and Rest of World compliance groups. Performs all other related duties as required.

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