James Bennett Email & Phone Number

Carlsbad, Ca, Us

Lead the Quality & Regulatory teams through transfer of legal manufacturing to Medtronic.Serve as the authorized PRRC and ensure overall Quality Management System compliance with applicable regulatory requirements.Manage the Quality Engineering, Complaint Handling, Receiving Inspection, Document Control, and Regulatory Affairs teams.Oversee Complaint Handling, Regulatory Reporting, Trending, NC/CAPA, Product Field Action, Risk Management, Training, and Supplier Management.Responsible for Design Control, Device Master & Device History records, Labeling review, Technical Files, and Documentation Control.Provide strategic and operational leadership for all global regulatory activities.Lead and manage all internal and external audit functions and coordinate third-party audits.Support Operations in achieving production metrics, including resolution of quality issues.

Provided hands-on leadership to the Complaint Handling and Document Control teams.Directly managed the Quality Management System and ensured compliance with applicable regulatory requirements.Responsible for Complaint Handling, Regulatory Reporting, Trending, NC/CAPA, Training, Management Review, External Standard Management, and audit coordination/response.Drove continuous improvement activities to reduce complaint aging and support timely CAPA closure.Participated in establishing strategic plans and objectives. Provided guidance and support to process users in Quality Engineering, Operations, and R&D functions.

Provided strategic leadership following Chapter 11 filing and pending asset purchase. Managed the Quality System, including Complaint Handling, Regulatory Reporting, Trending, NC/CAPA, Risk Management, Patient Device Tracking, Document Control, Supplier Management, and audit processes.Led manufacturing activities, including inspection and deviation resolution.Executed risk management process improvement to align with post market surveillance data collection.

Managed the Complaint Handling team through the execution of timely complaint investigations.Drove continuous improvement of the complaint handling process, including intake, investigation, failure analysis, regulatory reporting, trending, and the resulting link to risk and CAPA processes.Executed restructure of CAPA process to reduce aging and ensure timely investigation/resolution.Rebuilt Patient Tracking process to facilitate availability of implant data.Mentored Technical Solutions team to ensure capture of consistent complaint intake information.

Allendale, New Jersey

Led integration of complaint handling systems following an acquisition, including procedural updates and training. Managed the NC/CAPA process and contributed to NC assessments, CAPA investigations, Post-Market Health Risk Assessments, Health Hazard Evaluations, and Recalls.Managed the Internal Audit team and served as Subject Matter Expert for all Post-Market Surveillance related activities. Traveled internationally for audit support when necessary.Developed the strategy to successfully meet the Post-Market Surveillance EU MDR requirements.Supported new product development and risk management.

Allendale, New Jersey

Managed the complaint handling team and participated in root cause investigations and approvals.Supervised the complaint trending process and actively participated in Complaint Trend Review Board with members of senior leadership. Participated in NC/CAPA Board and facilitated resolution of quality issues.Led complaint coding overhaul to drive consistent capture of complaint data for trending purposes.

Austin, Texas Area

Supervised teams performing complaint handling and regulatory reporting activities across multiple product lines.Established extension team in Austin, TX to support an international counterpart. Supervised global Vigilance activities including approvals, training, and guidance. Traveled as necessary.Facilitated integration of complaint handling systems following multiple acquisitions. Conducted CAPA investigations and established Quality Plans to drive process improvements.Audited complaint records for consistency.

Austin, Texas Area

Provided guidance to the complaint handling teams.Completed Actavis Certified Trainer program and served as department trainer for 80+ employees. Travelled internationally to train a remote complaint intake group located in the Philippines.Served as a designated member of the Medical Device Reporting team, responsible for collecting and reviewing all complaint data quarterly, prior to submission to FDA.Performed site audit of a third-party vendor site responsible for implant device tracking activities.

Austin, Texas Area

Executed complaint handling activities and submission of associated regulatory reports.Served as lead for targeted pathology complaint handling for diseases of particular interest to FDA.

Austin, Texas Area

Spearheaded the development of a relocated team at a new site in Austin, Texas.Initiated complaint files, provided status updates, and processed claims in accordance with internal warranty policy.

Santa Barbara, California Area

Initiated complaint files, provided claim status updates, processed claims for financial reimbursement and replacement products in accordance with Allergan's internal warranty policy.

Santa Barbara, California Area

Performed application intake for applicants enrolling in LAP-BAND® workshops.Maintained correspondence between physicians and sales representatives regarding upcoming workshops and surgeon certifications.Updated workshop itinerary and materials necessary for the success of the course.Attended a three day LAP-BAND® workshop in Chicago to acquire additional product knowledge.

Oxnard, California

Completed five rotations throughout the hospital amounting to 240 hours of valuable experience. Participated in rotations including: Medical-surgery, Labor & Delivery, Emergency Room, and two rotations in the Operating Room. Tasks included general patient care; bathing and feeding patients, cleaning, making beds, observing surgeries, and assisting the nurses or other medical personnel wherever needed.Upon completion of the five rotations, served as Department Coordinator of thirty interns working in the Rehabilitation Department for the subsequent three month rotation.