• Manager of Regulatory Affairs

    Job Locations US-MN-Minneapolis
    Posted Date 1 week ago(2/8/2019 2:25 PM)
    Job System ID
    2019-6694
  • Overview

    Grason-Stadler (GSI) was founded in 1949 as an audiologic equipment company; providing instrumentation for research and clinical measurement in the field of hearing. By 1952, GSI was recognized as a technology leader and introduced one of the first clinical audiometers to the market. To this day, GSI is recognized as a world leader in audiometric assessment instrumentation by serving hearing health professionals in over 70 countries.  GSI offers a full line of audiometers, middle ear analyzers, otoacoustic emissions and auditory evoked potential instruments for all clinical, diagnostic and screening environments. Grason-Stadler’s mission is to set the standard in clinical audiology.

    Responsibilities

    General Position Description:

    Responsible for managing all regulatory submissions and regulatory documentation to support compliance for GSI, regulatory support assistance for all Diagnostic Group Companies. Responsible for helping to ensure regulatory requirements are implemented and maintained across all companies. Provide support for international registrations and support to global regulatory affairs teams when necessary. 

     

    Assist in GSI Research and Development in support documentation including but not limited to safety and FDA, certification issues. From time to time assist in project management with research and development projects at GSI. 

      

    Responsibilities and Duties:

    • Provide on-going regulatory support for the products and manufacturing/design facilities.
    • EMC and ETL (Intertek) safety testing/certification activities
    • Coordinating the activities with the outside test facilities
    • Pulling together the necessary supporting documentation and filling out checklists in support of testing/certification activities.
    • Creating and/or updating the necessary project documentation for new product development projects.
    • Document Development and Ownership:
    • Standards & Regulatory Requirements
    • Risk Management File
    • Usability Management File
    • FDA Level of Concern
    • SOUP/OTS Evaluation
    • Labeling Requirements
    • Usability and validation Plan
    • Product Uncertainty Report
    • MDD Annex 1 Essential requirements
    • MDD 93/42/EEC Compliance Statement
    • EC Declaration of Conformity
    • CE Instrument List
    • Biocompatibility report
    • FDA 510K
    • Verification plans and records.
    • Help maintain necessary documentation in Enovia and Qpulse.
    • Product Uncertainty Report
    • Manage regulatory body audits for Diagnostic Group Minnesota Office and assist in Med RX (Tampa) and MicroMedical (Chatam Ill)
    • Manage, prepare and submit 510(k) Premarket Notification and Design Dossier submissions.
    • Provide training to employees where necessary.
    • Serve as FDA contact for new submissions.
    • Renew and update FDA registrations, product listings and Canadian licenses.
    • Provide information and support to the registrations team for international registrations.
    • Assist Denmark, German regulatory affairs when requested.
    • Serve as a regulatory representative on new product development teams.
    • Review and approve technical literature (labeling, IFU’s, manuals, patient guides, etc.), sales and marketing literature, and reimbursement literature related to company products.
    • Review and approve pre-launch product submissions to ensure compliance with internal company requirements and compliance with regulatory requirements.
    • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
    • Review and analyze data generated for post market surveillance.
    • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
    • Consult with OEM customers regarding regulatory issues such as labeling etc.

    Qualifications

    Skills/Qualifications/Attributes

    • Previous experience in medical device regulatory environment.
    • Must be experienced at preparing and submitting technical documentation for all product submissions.
    • Solid knowledge of US, European and international regulations.
    • Excellent technical writing skills.
    • Excellent interpersonal skills.
    • Ability to work in a timeline driven environment.
    • Team Oriented, Fluent in a Multi-Cultural Environment
    • Project management skills

    Experience and or Education Requirements:

    • Technical degree or 5+ years regulatory experience in medical devices.

    Physical Requirements (Include Travel):  Occasional travel including international travel.

     

    We are an Equal Opportunity / Affirmative Action employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.

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