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 4,400 employees worldwide. Integra s common stock is listed on The NASDAQ Stock Market under the symbol IART. Responsibilities
The Sr. Regulatory Affairs Specialist will develop and implement global regulatory strategies based on US FDA regulations, European Medical Device Directive, External Standards, and other international regulations. This individual prepares on time medical device submissions for US and EU. This individual facilitates timely regulatory clearances/approvals. This individual represents regulatory affairs on project/product development teams. This individual reviews and approves product/facility change orders and labeling/promotional material. This individual assists with international registration requests to support international growth. This individual works with their manager to prioritize regulatory workload based on compliance and business objectives. This individual works with their manager to make regulatory decisions that allow the company to achieve its goals while maintaining regulatory compliance. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with minimal oversight.
Posted on : Sat, 20 Apr 2019 19:30:43 GMT
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