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, surgical instrumentation and 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, and wound care. 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 portfolio now includes 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 3,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
The Sr. Regulatory Affairs Specialist supports the manufacturing of Class II (US), IIb and III (EU) electrical/mechanical medical devices and related components and accessories. This individual reviews and approves all related change orders and performs the necessary regulatory assessments, working with a larger regulatory team to determine pre-approval requirements. This individual is responsible for the development and maintenance of EU product files including Class III design dossiers and Class IIb, IIa and Is technical files which facilitates timely regulatory approvals. This individual represents regulatory affairs on project/product development teams and will be responsible for the development and implementation of global regulatory strategies based on US FDA regulations, European Medical Device Directive, External Standards, and other international regulations. This individual perform analysis of complaints to determine if the incident is reportable under EU MDD/MDV requirements and completes MDV documentation for on-time filing. 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.
This individual must have at minimum a Bachelor’s degree (or equivalent international degree) with 3-5 years of experience or equivalent combination of education and experience in supporting manufacturing of medical devices. This individual must have proven skills in the developing CE registrations and US PMA/510(k) Premarket Notifications. This individual must possess knowledge of US FDA regulations, ISO Standards, and European Medical Device Directive (MDD). This individual must have experience working with US FDA, European Notified Bodies and Competent Authorities and other regulatory agencies. The individual must have strong writing, data analysis, and communication skills. The individual must have the ability to handle multiple demanding projects.
 Positions outside the US need only to have experience in the preparation of CE files.