Sr. Regulatory Affairs Specialist

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 This individual will be responsible for development and preparation of foreign and domestic regulatory submissions. Knowledge of ISO 13485 and CE Mark certification requirements, 510(k) / PMA / IDE submission requirements, and FDA QSR regulations is required. Demonstrated excellence in technical writing and oral communication skills is required. Medical Device Regulatory experience is required. Experience with orthopedic implants and Clinical Affairs is desirable. Review and compile appropriate technical information and clinical data into Technical Files and regulatory submissions to appropriate regulating authorities. Based upon the available technical information and clinical data, determine additional information needed to complete regulatory submissions. In conjunction with other departments and resources, plan and coordinate the efforts to generate and produce this additional information. In conjunction with marketing and senior management, work with and develop appropriate international distributor relationships necessary to support marketing applications in various countries. Develop and/or review product labeling for compliance with appropriate medical device standards and regulations, including instructions/information for use, package labeling, surgical technique descriptions, video instruction tapes, and product and company brochures and advertising. Work with quality assurance and other departments to ensure corporate compliance with appropriate regulations prior to and during audits. Work with Clinical Affairs to support pre and post market clinical activities

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