• Senior Regulatory Compliance Specialist

    Posted Date 8 months ago(11/1/2018 1:32 PM)
    City
    Irving
    State/Province
    Texas
  • Overview:

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    Do you want to be a part of a cooperative, inclusive, and high -performance environment?

    Well today is your lucky day because Celanese may be the company you are looking for. Let us explain what Celanese is all about and how our system works. Celanese Corporation is a Fortune 400 company. Our headquarters are located in Dallas, Texas. With nearly 7700 employees located throughout our 42 global manufacturing facilities, we are an industry leader in using advanced technology to produce materials included in products vital to everyday use such as automotive, electronics, pharmaceuticals, and paints. Our company takes pride in maintaining management of high financial, social, safety and environmental responsibility in everything it does. We are recognized by Glassdoor for treatment of our employees and global customers, and offer our employees outstanding benefits, including a 401K designed to ensure long term financial security. Our company focuses on the cooperation of its employees, provides competitive salary, and emphasizes giving back to the community. For more information about Celanese and our products please visit www.celanese.com

    Responsibilities:

    This position was created to support the EM Medical Technologies team at their request.

    This person will:

    • Serve as the SME for for EU regulations in medical/pharmaceutical/healthcare applications.
    • Lead Product Risk Management Reviews
    • Assist customers with regulatory submissions
    • Manage correspondence with regulatory agencies, especially in the EU.

    Qualifications:

    • Strong understanding of EU regulatory framework for medical and pharmaceutical chemical manufacture.
    • Proficient in conducting and documenting regulatory product risk assessments.
    • Good understanding of GMP and quality principles as they apply to the medical and pharmaceutical product manufacture
    • Familiar with US and EU medical device and drug development process (MDD, MDR, 510K, IND, NDA, ANDA).
    • Familiar with MAF, DMF and eCTD format required.
    • Ability to interpret regulations and translate regulatory requirements into compliance strategies.
    • Ability to manage multiple projects in a fast paced environment.
    • Ability to effectively oversee projects outsourced to consultants/laboratories.

    Required Years of Experience

    • Minimum 3 years regulatory/product stewardship experience in medical or pharmaceutical area.
    • 5 - 7 years preferred

    Required Education

    • Bachelor of Science in Chemistry, Biological or Life Sciences (biochemistry, toxicology, etc)

    Application Methods:

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