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Senior Regulatory Affairs Specialist

Company: Abbott Laboratories
Location: Des Plaines
Posted on: April 9, 2021

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions. Abbott's life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of peopleAbbott Molecular Our Des Plaines, IL site has an opportunity for Senior Regulatory Affairs SpecialistResponsible for providing strategy for protocols and approves product testing protocols and reports, and product approval regulatory strategies under the direction of the Regulatory Affairs Director.Support project teams to obtain worldwide regulatory approval or clearance for company molecular products and provide regulatory support to ensure compliance with all FDA and international regulatory requirements. Develop global regulatory strategies for new and modified products.Participate in and provide input to project teams to assure that international product registrations and licensing applications (original submission and subsequent product enhancements) meet regulatory requirements.Responsible for utilizing knowledge and experience in In-Vitro Diagnostic (IVD) medical devices/software in preparing and submitting international product registrations and licensing applications for multiple risk class products globally. Responsible for understanding, investigating and evaluating regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval, and determine trade issues to anticipate regulatory obstacles. Responsible for providing regulatory representation and support for design review, design change and design transfer through product lifecycle.Maintain technical expertise through familiarity with the literature, attendance at professional meetings and participation in team meetings. Interpret new or existing regulatory requirements as they relate to molecular products and procedures. Review and advise on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulations. Comply with applicable Corporate and Divisional Policies and procedures. EDUCATION AND EXPERIENCE YOU'LL BRING: Master's or foreign equivalent degree in a Pharmacy, Pharmacology, Biomedical Engineering, Regulatory Affairs/Science or in a closely related concentration (Will accept a Bachelor's degree in the above fields + 5 years of related progressive experience in lieu of a Master's degree) each alternative with at least 1 year of experience in: (i) Preparing and submitting international product registrations and licensing applications multiple risk class products globally for In-Vitro Diagnostic (IVD) medical devices/software; (ii) understanding, investigating and evaluating regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval, and determine trade issues to anticipate regulatory obstacles; and (iii) providing regulatory representation and support for design review, design change and design transfer throughout the product lifecycle. Employer will accept any suitable combination of education, training, or experience. Required

  • Bachelor's degree in science (biology, chemistry, microbiology, immunology ,medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area.
    • 5 years experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience Preferred
      • M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
        • Regulatory Knowledge of (as applicable):
          • Regulatory history, guidelines, policies, standards, practices, requirements and precedents
          • Regulatory agency structure, processes and key personnel
          • Principles and requirements of applicable product laws
          • Submission/registration types and requirements
          • GxPs (GCPs, GLPs, GMPs)
          • Principles and requirements of promotion, advertising and labeling
          • International treaties and regional, national, local and territorial trade requirements, agreements and considerations
          • Domestic and international regulatory guidelines, policies and regulations
          • Ethical guidelines of the regulatory profession, clinical research and regulatory process WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer: --- Training and career development, with onboarding programs for new employees and tuition assistance --- Financial security through competitive compensation, incentives and retirement plans --- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs --- Paid time off --- 401(k) retirement savings with a generous company match --- The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully:

Keywords: Abbott Laboratories, Des Plaines , Senior Regulatory Affairs Specialist, Other , Des Plaines, Illinois

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