Manager Regulatory Compliance - Product Recalls (IRC7218)
Location: Plainsboro New Jersey
Description: Integra LifeSciences is at the momment seeking for Manager Regulatory Compliance - Product Recalls (IRC7218) right now, this career will be placed in New Jersey. Detailed specification about this career opportunity kindly read the description below. Integra LifeSciences, a world leader in medical devices, is dedicated to limiting uncertainty for surgeons, s! o 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 S! mall 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 The Manager Regulatory Compliance (Product Recalls) supports the management of ongoing compliance initiatives. The position will be required to plan, direct and execute all regulatory compliance functions and programs for Corporate Regulatory Affairs. This individual must possess the ability to establish and maintain effective working relationships with Integra Team members worldwide.
Job Requirements Coordinate compliance risk assessment and risk analysis, Health Hazard Evaluations (HHE's), Corrective and Preventive Actions (CAPA's), Field Corrections and Removals (Recalls) and other general compliance issues across Divisions and Facilities. Consider innovative solutions to meet the changing regulatory compliance environment and compliance goals. Publish and disseminate compliance updates to Corporate, Division and Facility! management to include metrics as applicable. Assist and support Facilities in the preparation and during FDA and regulatory agency audits / inspections. Participate in regulatory compliance training as required subsequent to issuance of new and revised SOP's. Manage corporate regulatory compliance documentation as it relates to SOP development and maintenance, and the coordination of risk assessment activities (HHE process), post-market vigilance reporting and field corrections and removals (Recalls). Periodically assess the organizational structure, procedures, processes, and resources to ensure adequate compliance to meet both the needs of the business and regulatory agency requirements. Participate in regulatory compliance initiatives as related to due diligence reviews for potential acquisitions. Support the integration of Compliance into Quality Leadership Development 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.
To find out more about our company, visit our website at: http://www.integralife.com/Careers/
No Agencies. LOCAL CANDIDATES ONLY PLEASE. EOE, M/F, D/V
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.
- .
If you were eligible to this career, please email us your resume, with salary requirements and a resume to Integra LifeSciences.
If you interested on this career just click on the Apply button, you will be redirected to the official website
This career starts available on: Sat, 18 May 2013 18:57:49 GMT
Apply Manager Regulatory Compliance - Product Recalls (IRC7218) Here