• Manager of Regulatory Affairs

    Job Locations US-MN-Minneapolis
    Posted Date 2 months ago(2/20/2019 9:19 AM)
    Job System ID
  • 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.


    Responsible for managing all regulatory submissions and regulatory documentation to support compliance for GSI, as well as 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 Research and Development in generation of the documentation needed for, but not limited to, safety, EMC, FDA, certification issues, and other regulatory requirements. From time to time, assist in project management of research and development projects at GSI. 


    Responsibilities and Duties:

    • Provide on-going regulatory support for the products and manufacturing/design facilities.
    • Preparation and coordination activities related to EMC and safety testing/certification
    • Generation, coordination, and organization of the necessary supporting documentation and filling out checklists required for testing/certification activities.
    • Creating and/or updating project documentation for new product development projects.
    • Document development and ownership of, but limited to the following:
    • Standards & Regulatory Requirements
    • Risk Management File
    • Usability Management File
    • FDA Level of Concern
    • SOUP/OTS Evaluation
    • Labeling Requirements
    • Usability and validation Plan
    • MDD Annex 1 Essential requirements
    • MDD 93/42/EEC Compliance Statement
    • EC Declaration of Conformity
    • CE Instrument List
    • Biocompatibility report
    • FDA 510K
    • Help maintain relevant records in the document management system.
    • Manage regulatory body audits for Diagnostic Group Minnesota office and assist sister organizations as requested.
    • Manage, prepare, and submit 510(k) Premarket Notification and Design Dossier submissions.
    • Provide regulatory related training to employees.
    • 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 internal regulatory affairs groups in sister organization as 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.
    • Coordinate and address OEM customers regulatory issues


    • 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. 
    • 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

    Physical Requirements (Include Travel):  Occasional travel (domestic and international)


    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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