Quality Compliance Specialist - Product Recalls (IRC7283)
Location: Plainsboro New Jersey
Description: Integra LifeSciences is currently interviewing Quality Compliance Specialist - Product Recalls (IRC7283) right now, this vacancy will be placed in New Jersey. Further informations about this vacancy opportunity please give attention to these descriptions. Integra LifeSciences, a world leader in medical devices, is dedicated to limiting uncertainty for surge! ons, 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 ar! e open to new opportunities and derive satisfaction from knowing that their efforts are making a difference in someone’s life.
Detailed Description The Quality Compliance Specialist supports the effective implementation of Integra's Health Hazard Evaluation (HHE) and Field Correction / Removal (Recall) processes based on U.S. and International requirements. The position requires participation in, and at times lead, activities that determine the level of patient risk associated with Integra products in the marketplace and if that risk meets regulatory thresholds to execute correction or removal of product in the marketplace. The individual must possess the ability to establish and maintain effective working relationships with Integra Team members worldwide.
Job Requirements Initiate HHE's and maintain the corporate working and completed HHE archive files Participate in, and where appropriate lead, team meetings and activities where HHE's are developed the poin! t of approval. Assure HHE documentation is complete, accurate and addresses regulatory requirements prior to approval. Provide approved HHE's to the Field Action Committee (FAC) and resolve any questions / comments Continually monitor and provide routine reports to management on the progress to completion of HHE's. Coordinate and where appropriate lead, team meetings and activities to complete the documentation needed to initiate global corrections and removals. In conjunction with other global RA functions, prepare documented recall strategies for review and approval. Ensure corporate working and completed correction / removal files are maintained and archived. When needed to increase recall effectiveness, develop and use alternate methods to identify and contact customers affected by a recall. Prepare correction / removal status updates to US regulatory authorities and submit on a timely basis. Prepare correction / removal close-out reports to US regulatory authorities fo! r internal review and submit after approval Continually monitor and pro! vide routine reports to management on the progress to completion of corrections / removals. Provide support and / or participates in regulatory audits/inspections as required. Write and or revise department procedures as needed. Keep apprised of new regulations, standards, policies, and guidance documents issued by relevant regulatory authorities that may impact HHE's, corrections and removals. Performs all other related duties as directed by management EDUCATION / EXPERIENCE
Bachelor’s Degree related area study preferred 3 - 5 years experience in a medical device or pharmaceutical company responsible for administration of health hazard evaluations, post market risk assessment, and recalls Regulatory Affairs Certified (RAC) preferred Computer skills to include knowledge and experience with Excel, Sharepoint and proficient use of the worldwide web network Strong writing, project management, and communication skills. How To Apply We are committed to creating an environm! ent 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 partnersh! ips 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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If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Integra LifeSciences.
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This vacancy starts available on: Sun, 05 May 2013 18:46:00 GMT
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