1+ months

Senior Specialist Regulatory Affairs

Abbott
Des Plaines, IL 60016

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 103,000 colleagues serve people in more than 160 countries.

Senior Specialist Regulatory Affairs

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world - in nutrition, diagnostics, medical devices and branded generic pharmaceuticals - that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

At Abbott Molecular, we realize the potential of personalized care as the laboratory’s most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics.

The Senior Regulatory Affairs Specialist is responsible for directing and coordinating the

implementation of regulatory compliance programs as required by federal, state, and

local government agencies at the Abbott Molecular, Inc.

This includes achieving government registration and licensure approval of new products and assuring that current products and manufacturing operations are in compliance with applicable

regulations.

Responsibilities:

  • Responsible 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 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 / Skills / Experience:

    • 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 ) utilizing knowledge and experience in electronic medical devices/software in preparing and submitting PMA, and international product registrations and licensing applications for Class III medical devices (original submission and subsequent product enhancements);

      (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 through product life-cycle. Employer will accept any suitable combination of education, training, or experience.

      ","industry":"Healthcare","title":"Senior Specialist Regulatory AffairsDivision: AMD Molecular
      Travel: No
      Medical Surveillance: No
      Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Posted: 2020-06-01 Expires: 2020-07-17

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Senior Specialist Regulatory Affairs

Abbott
Des Plaines, IL 60016

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