• Senior PS Specialist

    Posted Date 2 weeks ago(11/1/2018 1:32 PM)
    City
    Las Colinas
    State/Province
    Texas
  • Overview:

    Celanese Corporation is a global technology leader in the production of specialty materials and chemical products which are used in most major industries and consumer applications. Our products, essential to everyday living, are manufactured in North America, Europe and Asia. Known for operational excellence, sustainability and premier safety performance, Celanese delivers value to customers around the globe with best-in-class technologies. Based in Dallas, Texas, the company employs approximately 7,500 employees worldwide and had 2014 net sales of $6.8 billion, with approximately 67% generated outside of North America. For more information about Celanese Corporation and its global product offerings, 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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