Integra LifeSciences Holdings Corporation, a world leader in regenerative medicine, is a global medical device company dedicated to improving the quality of life for millions of patients every year.

Our products are used primarily in orthopedics, neurosurgery and general surgery.

We are a leader in applying the principles of biotechnology to medical devices, particularly for neurosurgery and extremity reconstruction, and are one of the largest surgical instrument companies in the US Headquartered in Plainsboro, New Jersey, Integra has research and manufacturing facilities throughout the world.

Integra has been repeatedly named as one of Forbes 200 Best Small Companies and was listed as one of New Jersey's 50 Fastest Growing Companies by NJBIZ in 2009.

We were also selected as one of the Medical Device Manufacturers of the Year by Medical Device & Diagnostic Industry Magazine in 2007.

We value innovative thinkers who are open to new opportunities.

We are looking for self-motivated people who like being challenged and derive satisfaction from knowing that their efforts are making a difference in someone's life.

The Quality & Regulatory Manager will function as a member of a team charged with business process improvement and the implementation of the Oracle ERP solution.

This position will function within the Plan-to-Manufacture process team to develop optimized processes and standards, define and validate the Oracle solution and provide guidance and support to the business during the testing and deployment phases.

Work with senior management to gather and evaluate business requirements through planned meetings, user-group work sessions, and individual interviews.

Participate in solution reviews and provide ongoing feedback on selected solution?s implementation status and timeline.

Propose recommendations to streamline core business processes, minimizing complexity, training effort and data duplication.

Create and maintain mappings of current and future business process flowcharts.

Design and document the global business solution: business processes and application solutionsWork with IS resources to configure the software solution and with the business to test the software the solution.

Participate in training programs and develop user documentation Provide daily/weekly updates to the global project manager; escalate unresolved issues in a timely manner.

DESIRED MINIMUM QUALIFICATIONS10+ years experience in Quality and RegulatoryBachelor degree in a related fieldGraduate degree preferred5+ years experience in project management Quality and Regulatory/ERP implementation experience preferred GENERAL PROFILE: Credibility and Leadership in his/her organizationForward thinker ? ability to focus on long term solutions and business evolutionPositive attitudeStrong communicator ? ability to define and communicate business issues, with experience building close relationships and engaging senior management.

Open minded and flexibleProvide business leadership and inspiration to the teamBroad industry experience and knowledge of ?best practices? for their area of expertise.

PROFESSIONAL KNOWLEDGE: QualityQuality Reporting/Measures/KPIsQuality activities related toManufacturingServicePurchasingStrong knowledge of Inventory and Shop FloorQuality Specifications Collection ElementsCollection Plans & Data CollectionFDA & GxP requirements, AuditRegulatory Regulatory Reporting/Measures/KPIsRegulatory activities related toManufacturingProduct LabelingOrder ManagementShipping & CustomsFDA & GxP requirements 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.integra-ls.com/home/careers /No Agencies.

LOCAL CANDIDATES ONLY PLEASE.

EOE, M/F, D/VIntegra 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.

Please click the following URL to apply for this job https://erpiapps.

integra-ls.com/OA_HTML/OA.jsp?OAFunc=IRC_VIS_VAC_DISPLAY&p_svid=2818&p_spid=88718&p_site_id=21

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