• Quality Assurance & Regulatory Affairs Consultant

    Location GB-Cambridge
    Job ID
    # of Openings
    Job Category
  • Responsibilities

    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).


    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.




    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.


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