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Regulatory Affairs Specialist

Abbott Laboratories

This is a Contract position in Phoenix, AZ posted October 11, 2021.

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.

About Abbott The key to successful treatment and full recovery is often fast, accurate diagnosis.

Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

Our location in Chicago, IL currently has an opportunity for a Regulatory Affairs Specialist.

The position of Regulatory Affairs Specialist is within our Cardiometabolic and Informatics Unit.

This role will contribute to the Regulatory Affairs’ function in ATN with responsibilities for product registrations, product labeling and incident reporting.

The role is critical to ensure products are registered in all markets where required and that registrations are maintained throughout the life cycle of the products.

WHAT YOU’LL DO The Regulatory Affairs Specialist will provide support for the regulatory department to ensure efficient and compliant business processes and environment.

This individual may execute tasks and exercise influence generally at the middle management level.

The person hired may also assist in the registration of products by preparing and submitting documentation needed for registration worldwide.

In addition, the person hired will make an impact in this role by the following ways: Provide regulatory input to product lifecycle planning.

Assist in SOP development and review.

Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.

Determine trade issues to anticipate regulatory obstacles.

Participate in risk benefit analysis for regulatory compliance.

Determine and communicate submission and approval requirements.

Monitor applications under regulatory review.

Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.

Assist in preparation and review of regulatory submission to authorities.

Maintain annual licenses, registrations, listings and patent information.

Assist compliance with product post marketing approval requirements.

Assist in the review of advertising and promotional items.

Ensure product safety issues and product associated events are reported to regulatory agencies.

Provide regulatory input for product recalls and recall communications.

EDUCATION AND EXPERIENCE YOU’LL BRING Required Bachelor’s degree in related field or HS Diploma and 7 years of work experience equivalent to this role.

Three or more years of relevant experience in a similar role.

Preferred Bachelor’s/Master’s degree in natural science Experience in IVD regulations At least two years of experience in Regulatory Affairs and Quality Assurance FDA regulation knowledge/experience One year or more of experience with investigating regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.

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: Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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