Senior Regulatory Affairs Specialist
Company: Abbott Laboratories
Location: Des Plaines
Posted on: April 9, 2021
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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
Keywords: Abbott Laboratories, Des Plaines , Senior Regulatory Affairs Specialist, Other , Des Plaines, Illinois
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