• Principal Product Steward (m/w)

    Posted Date 4 weeks ago(14/11/2018 9:26 AM)
    Requisition ID
    2018-8971
    Country
    Germany
    City
    Sulzbach (Taunus)
  • Overview:

    In the past one hundred years, Celanese has transformed into a global technology and specialty materials company with leading businesses in key geographic regions. With a focus on safety, innovation, productivity, performance and results, our company is positioned to achieve significant future growth and deliver exceptional results for all stakeholders.

     

    While we call Dallas, Texas home for our headquarters, we have approximately 7,500 employees working to serve our customers around the world. From Dallas to Amsterdam to Shanghai, we manage a global network of commercial offices, technical centers, and twenty-seven production facilities and additional strategic affiliate production facilities.

     

    For more information, visit https://www.celanese.com/

     

    We’re engineers, scientists, operators and product developers. We’re innovators, advisers, designers and problem solvers. Most importantly, we’re partners – in creating value for our customers with the solutions we offer and in improving the world through the actions of our colleagues.

     

    Celanese is The Chemistry Inside Innovation™ and we aspire to be the first-choice chemistry solution source for our customers.

     

    We know what you’re thinking – that’s a lot to promise and that’s a lot to do. Well, we would agree with you, but we’re up for the challenge and we owe it to our customers, shareholders, and employees to deliver on our promise.

    Currently we are looking for candidates for the following position:

     

    Responsibilities:

    • Support the Engineered Materials (EM) Medical Technologies Team
    • Serve as the Subject Matter Expert (SME) and ensure regulatory compliance of EM products used in medical/pharmaceutical/healthcare applications
    • Lead Product Risk Management Reviews
    • Assist customers with regulatory submissions
    • Manage correspondence with regulatory agencies, especially in the EU
    • Develop, maintain and where appropriate, optimize product stewardship processes
    • Represent Celanese in industry associations as assigned

    Qualifications:

    • Bachelor of Science in Chemistry, Biological or Life Sciences (biochemistry, toxicology, etc.)
    • Minimum 5 years regulatory/ product stewardship experience in medical or pharmaceutical area (7-10 years preferred)
    • Strong understanding of EU regulatory framework for medical and pharmaceutical chemical manufacture
    • Proficiency 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
    • Strong working knowledge of US and EU medical device and drug development process (MDD, MDR, 510K, IND, NDA, ANDA)
    • Familiarity with MAF, DMF and eCTD format required
    • Ability to interpret regulations and translate regulatory requirements into compliance strategies
    • Experience supervising people is highly desired

    Apply:

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