• Quality Assurance & Regulatory Affairs Consultant

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

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    Contribute to a Safer, More Secure, and More Sustainable World. At UL, we know why we come to work. Thousands of us around the world wake up every day with one common purpose – to make the world a safer, more secure, and more sustainable place to live. We clear the way for our customers to introduce the latest products, technological advances, and systems in an increasingly complex world so they can provide peace of mind to the market. We are proud that the work we do every day has a meaningful contribution to society. This helps us to sleep better at night, and we are confident that the millions of people we touch rest easier too.

     

    What can we offer you?
    Grow and Achieve. Growth and development are part of our DNA. Experience from your first day our robust structures, quick decision making paths and corporate culture that encourages achievement based on trust.
    Be as international as it gets by working with colleagues across different cultures and also get inspired and supported from senior colleagues and leaders.

     

    As part of UL, 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 in Home-Office

     

    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%

     

    Look at what we can do together!
    You’ve learned about us – now we would like to learn more about you. Apply now on-line as we are eager to soon be able to welcome you in the TEAM!
    Your contact person is Rodin Dragoescu under 069-489810285 or: rodin.dragoescu(at)ul.com

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