Brahim Hadri; RAC

Experience

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  Analogic

  Jan 1989 - Oct 2003

  Senior Lead for Regulatory Affairs (Computed Tomography Division)

  Senior Lead for Regulatory Affairs (Computed Tomography Division) 2001-2003 Manager for Regulatory Affairs (Telecom Division) 1999 to 2001 Manager for Compliance and Safety Engineering (Corporate Division) 1997 to 1999 Senior Engineer for Compliance and Safety (Corporate Division) 1989 to 1997

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  NeuroLogica

  Feb 2004 - Nov 2005

  Manager for Regulatory Affairs and Quality System

  • Developed and implemented a total quality management system (QMS) from the ground up resulting in a formal certification to ISO 13485-2003 QMS, CMDCAS, Annex II of the European Medical Device Directive MDD 93/42/EEC and FDA 21 CFR 820 GMP/QSR.• Managed the day-to-day activities for continued compliance and improvement of ISO QMS including SOP generation and maintenance, audits, CAPA, customer complaint processing and management reporting.• Managed the regulatory aspects of Neurologica’s NL3000 CT and NL1000 SPECT Scanners including the preparation, submission of correspondence and applications to regulatory agencies FDA CDRH division, EU notified body and local third party agencies. Maintenance of 510(k) and CE mark.• Prepared and managed product construction reports and technical files (CE Marking, CB Report). Schedules and coordinates third-party safety testing process for compliance.• Established and executed regulatory policy and procedures including pre-market notification submissions, Medical Device Reporting and letters to file for decisions not to submit. Served as primary interface for all FDA activities.• Reviewed and approved device labeling and advertising materials for compliance with global regulations• Established a Product Development Procedure that served as the basis for design control including procedures for process and design verification/validation.• Assisted engineering groups efforts with regulatory representation for product development to ensure that regulatory, quality, and safety standards are incorporated into product specifications and processes specifically compliance to IEC general standard 60601-1 and its collaterals.• Supervised Safety and EMC/EMI testing from third party laboratories to meet FDA and MDD requirements Show less

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  GE Healthcare

  Jan 2005 - Oct 2007

  Sr. Regulatory Affairs Lead

  Key activities include regulatory management of new product introductions, submissions, clinical trials, safety compliance and audits. • Develop and implement Worldwide RA strategies (USA, EU, Canada, Japan and China) for diverse product, EM Imaging guided Surgery; Fluorescence Imaging guided Surgery and Navigated Surgical Instruments; X-ray Radiography, X-ray Fluoroscopy.• Develop; prepare and review regulatory submission 510(k); Initial Product Reports, Supplements and Annual Reports for Class I and II products to US FDA, European Notified Body and Health Canada. • Create and submit IDE plans for clinical investigation and studies for our Fluorescence Imaging guided Surgery System (Sites in USA and England) per FDA 21CFR812 and NF-14155-1/-2. Successfully negotiated final program requirements with the FDA in advance of program timeline requirements• Communicate and act as liaison with the FDA and other Authorities having jurisdiction in specific countries, to clarify the regulatory requirements’ gray areas especially with new technologies. • Support product development and field modification activities for key company products; areas covered includeo Bio-compatibility and Sterility assurance programs including ethylene oxide and steam sterilization for GE Navigated Surgical Instruments product line o Product safety and EMC/EMI design requirements to the latest edition of the IEC 60601 family of standards o Interface with design engineering team to review identified product regulatory, Bio-compatibility and Sterilization issues, and recommend solutions for complianceo Schedule and coordinate follow up audits with NRTL agencies. Direct and maintain all regulatory filings and communications with the Notified Bodies. Show less

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  Tornier

  Oct 2007 - Dec 2012

  Sr. Regulatory Affairs Specialist

  • Manage the Regulatory Affairs for Tornier US products portfolio (Orthopedics implants) and all of the activities associated with obtaining approvals.• Prepare regulatory submissions to obtain various worldwide approvals; successfully cleared 18 510ks; obtained approval for 5 CE Dossiers for EU Class III device; 12 Canadian Licenses for Class III. Expanded the product portfolio to Australia; Korea, Japan; and Latin America.• Take lead role in ongoing and FDA fully approved Tornier IDE study for Shoulder Prosthesis; manage pre-IDE meeting with USFDA; lead cross functional team for the drafting of the application;. Play a Key role in the execution of study, surgeon’s contacts and training; study monitoring and follow up. • Work directly with regulatory agencies to promote agreement on filing strategies or resolve problems. • Sets strategic direction for regulatory filings, clinical studies and define objectives and outputs; determine the cost, schedule, priority to accomplish objectives. • Provide post-market support and ensure regulatory compliance of market released products. • Lead research in and interpret current and emerging US and international regulations that may impact Tornier. • Provide on-going support to product development teams for regulatory issues Show less

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  Philips

  Jan 2013 - Mar 2016

  Senior Manager: Regulatory Affairs

  Leads multi-site Regulatory Affairs teams in support of project core teams:-Provide regulatory guidance and formulate strategies for efficient and timely approvals of product regulatory submissions worldwide including 510(k) Pre-market Notifications, Technical Files, Health Canada applications and Global STEDs.-Provide leadership and guidance to program teams on global compliance, such as CE Marking processes and product registrations, clinical evaluations in accordance with MDD Annex X & ISO 13485, Canadian CMDCAS, -Communicate, interact, at technical and management levels with external agencies (FDA; Notified Bodies; Global RA authorities)-Provide subject matter expertise for FDA 21CFR820.30 Design Control and Product Development (including in the areas of Risk Management; Specification Development and Verification/Validation of Hardware/Software; Change Control; Clinical Evaluation). Teamed up with R&D group to revamp those Design Control inter-processes for better alignment and efficiency.-Guide, direct, lead the creation and maintenance of regulatory compliant, competitive, and up to date global labeling and promotional process. Identify and track all factors that impact labeling updates including US and international regulatory changes (i.e. China; Russia; Latam).-Provide Support with external/internal Audits, RA review of HHE’s, US FDA Medical Device Reports and international medical device vigilance reporting and field actions.-Responsible for planning and maintaining Establishment Registrations, Device Listings, CE marks lists, and other regulatory agency documents (Annex II; V; and VII ISO certificates).-Lead the RA council for the Philips Healthcare Imaging System community to reviews the changes in the worldwide RA landscape and impacts on the business.-Take an active role within Philips Healthcare core team on FDA Unique Device Identification (UDI). Plan and coordinate for the implementation of the UDI requirements per FDA final rules. Show less

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  IBM

  Apr 2016 - Sept 2019

  Regulatory Affairs Manager