Regulatory Affairs Intern (IRC6327)
Integra LifeSciences - Plainsboro, NJ

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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 is a Regulatory Affairs Intern position intended to support corporate regulatory affairs in the preparation of PMA Supplements, 510(k) Premarket Notifications, and global Regulatory submissions for the transfer of manufacturing operation to Integra facilities; assist with internal and external compliance programs and site inspections by Federal and International regulatory agencies and, the creation and maintenance of labeling translations. In addition this position will support the develop and implementation of regulatory strategies and guidance based on U.S. and International requirements as defined in FDA Regulations, ISO 13485:2003 Standard, European Medical Device Directives, Canadian Medical Device Regulations, Japanese QMS Ordinance (Ministerial Ordinance No. 169), Australian Therapeutic Goods (Medical Devices) Regulations 2002 (No. 236) and other International Regulations. Establish effective dialogue with U.S. and International regulatory authorities.
Supports Corporate Regulatory Affairs in developing partnerships with operations, manufacturing Quality Systems, Engineering and Development in designing and enhancing regulatory initiatives to facilitate overall regulatory compliance. . Interact with and support Transfer Project teams in the review of final documents for corrections.. Aids in the preparation of PMS Supplements and 510(k) Premarket Notifications to FDA. Support the regulatory oversight of changes in manufacturing facilities, processes, procedures, and testing methods.. Assists in the review of documentation, protocols and reports received; and prepares additional written materials as needed.. Supports the coordination and preparation of 510(k) Premarket Notifications, PMA Supplements, Design Dossier and Technical Files and facilitates timely regulatory approvals for all product transfers. Assists in the preparation of responses to FDA letters, supplements, and amendments; and participates in FDA inspections and presentations as needed. Assist in the coordination, authorization and tracking of translations for the procut labeling and documents for the companies of Integra. Obtain labeling content information form appropriate sources and provide regulatory process guidance and assist contributors in becoming familiar with correct formats/procedures for labeling. Performs all other related duties as directed by supervisor and management.
Job Requirements Undergraduate or post graduate college students majoring in any of the biological or engineering sciences with acceptable GPA ratings are ideal candidates for this position. Previous relevant internships/coop experiences are helpful but not required. How To Apply We are committed to creating an environment where all employees are valued and respected. We offer a competitive benefits package including 401(K) savings plan with match, medical, vision, dental, life insurance, tuition reimbursement, and employee stock purchase plan.
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Integra is not currently accepting unsolicited assistance or resumes from search firms for this employment opportunity. All resumes submitted by search firms or agencies to Integra or its employees, agents, directors or representatives in any form or method without a valid written agreement covering this position will be deemed the sole property of Integra. No fee shall be paid in the event the candidate is hired by Integra as a result of the referral or through other means.
Search firms are essential to the recruitment and staffing efforts at Integra and we value the partnerships we have built with our preferred vendors. For this reason, Integra has established and regularly maintains a vendor list. Please note that even preferred vendors are required to have a written search agreement signed by an authorized signatory of Integra in order for a fee to be paid for any candidate referrals.

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When it comes to regenerative medicine, Integra LifeSciences is integral to the healing process. Using its proprietary collagen matrix...