• Quality Assurance & Regulatory Affairs Consultant

    Standort DE-Hamburg | DE-HE-Neu-Isenburg
    Stellencode
    10440
    Anzahl der offenen Stellen
    1
    Stellenkategorie
    Qualität
  • .

    Emergo is inviting applications from experienced, high caliber, European-based Medical Device specialists with the following attributes:

    Education:  Bachelor Degree required, preferably in area of life sciences, medical, or engineering

    Experience: At least 5 years in a quality assurance or regulatory affairs role; previous consulting experience is an advantage.

     

    Location: Although most positions will be home office based, candidates already based in the UK, Germany and/or northern Europe are preferred.

    Successful candidates will demonstrate the qualifications and competency to support the following areas of medical device consulting in the role of:

    Regulatory Affairs Consultant

    Objective:  To provide assistance to medical device manufacturing clients with developing regulatory strategies and obtaining premarket authorization for their products in key markets (primarily U.S., EU and Canada).

    Required technical and behavioral competencies:

    • Extensive knowledge of medical device regulatory requirements EU CE Marking per MDD/MDR and IVDD/IVDR and for US FDA.
    • Hands-on experience with EU Technical Files and knowledge of CE Marking requirements; Clinical Evaluation Report writing a plus.
    • Demonstrated experience with US 510(k) submissions, preferably with sole responsibility for completion.
    • Experience with other regulatory documents/submissions (US: 513(g), Pre-Subs, IDE; Canada: Class II-IV MDLs; EU: CERs).
    • German speaking (business fluency) is preferred

    Also Preferred:

    • Specific experience with software and/or IVD s will be considered a plus.
    • Experience with Animal Tissue justifications and/ or products is an advantage
    • Quality Assurance experience is a plus.

    Range of Expected Activities:

    • Research and advise on device classification and regulatory pathways and strategies.
    • Prepare and submit regulatory premarket submissions (510(k), technical files, Canada MDLs); communicate specific requirements for effective submissions.
    • Assist in addressing and responding to deficiencies of product submissions identified by regulatory bodies.
    • Prepare meeting requests between clients and the FDA, and facilitate those meetings.
    • Interact and negotiate directly with regulatory authorities and notified bodies on behalf of clients.
    • Assist clients with other regulatory concerns, such as labeling, promotion, design change evaluation, etc.
    • Author CERs to support CE marking.
    • Review documentation and advise clients in developing more effective documentation, e.g., risk management, labeling, reports.
    • Travel: 0% – 30%

    In addition, all successful consultant candidates will possess the following qualities:

    • Strong interpersonal skills and ability to work with all levels of a client’s organization.
    • Effective technical writing skills.
    • Ability to identify, understand and resolve issues.
    • Professional, but friendly demeanor; diplomatic but assertive.
    • Detail oriented
    • Effectively manages one’s time to ensure that work is completed efficiently and within the budgeted time, and is capable of successfully working on multiple projects.
    • Ability to understand the big picture and is business-focused.

     

     

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