HR Knowledge

  • Quality Assurance and Regulatory Affairs Specialist

    Job Locations US-MA-Wilmington
    Job ID
    2018-1224
    # of Openings
    1
    Category
    Engineering
  • Overview

    Our client, Spectra Medical Devices, Inc., is a world leader in needle production and innovation, Spectra has clearly advanced the field of ultrasound guided procedures with an innovative dimple design that takes the clarity of imaging to a new level, improving the safety and efficacy for physicians and patients.

    The Quality Assurance and Regulatory Affairs Specialist will be responsible to provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical device regulations in both the U.S. and globally. Provide regulatory support to marketed products and ensure company’s regulatory compliance status.

    Responsibilities

    • Prepare\ submit apps to FDA for clinical testing and marketing of new/modified medical devices (510(k)’s, Pre-Submissions)
    • Prepare documentation for filings (e.g., No 510(k) Rationales, Intl change notifications).
    • Prepare application doc for Intl marketing approvals (CE Mark Tech files and Dossiers, STED, Intl Dossier)
    • Assist Product Development\ QA in planning pre-clinical studies; bench testing for regulatory submissions
    • Review proposals for clinical design validations, clinical field trials; customer preference tests.
    • Represent regulatory affairs on prod dev teams to provide direction on regulatory/clinical requirements and strategy
    • Support the dev and implementation of Spectra regulatory processes, procedures, standards
    • Escalate\present CAPA program to Corp Mgmt
    • Support Manufacturing\Project Teams by developing FMEAs, statistically, and process controls.
    • Leads activities of non-conformances (MRB), Corrective & Preventative Actions (CAPA support), and complaints
    • Doc Change Order support
    • Internal Audit Program - Complete audits; prepare reports
    • Supplier Mgmt program -  Audit quality system of new\existing suppliers, prepare audit reports include recommendations
    • Ensure all projects are in compliance with GMP, QSR (including Design Controls), ISO

    Qualifications

    • Bachelor of Science required, with emphasis on life science or engineering
    • 3-5 yrs experience with quality and regulatory requirements for medical devices (ISO 13495:2003 and 13485:/2016, US FDA Quality System Requirements, Pre-Submissions, 510(k)’s, CE mark tech files, design dossiers)
    • Previous experience in supporting regulatory projects and R&D/Quality teams
    • Solid knowledge in FDA, EU regulations for medical device
    • Good oral and written communications skills and ability to work on cross-functional teams
    • Working knowledge of statistics and electronic documentation and information systems

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