Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of the office of our Lake Forest, IL location in the Infectious Diseases Business Unit of Abbott Diagnostics. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology.
What You’ll Work On
As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory
department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play
a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining
these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may
prepare and submit documentation needed for registration worldwide or may oversee such preparation.
In addition, If hired, you will also perform these essential job duties:
• Strategic Planning: Assist in SOP development and review. Provide regulatory input to product lifecycle planning. Continue
to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
• Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in
order to assess regulatory implications for approval. Determine trade issues to anticipate regulatory obstacles. Determine
and communicate submission and approval requirements. Participate in risk-benefit analysis for regulatory compliance.
• Premarket: Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile,
prepare, review and submit regulatory submission to authorities.
• Monitor impact of changing regulations on submission strategies. Monitor applications under regulatory review. Monitor and
submit applicable reports to regulatory authorities. Evaluate proposed preclinical, clinical and manufacturing changes for
regulatory filing strategies. Negotiate and interact with regulatory authorities during the development and review process
to ensure submission approval.
• Post market: Maintain annual licenses, registrations, listings and patent information. Assist compliance with product
post marketing approval requirements.
• Review and approve advertising and promotional items to ensure regulatory compliance. Assess external communications
relative to regulations. Review regulatory aspects of contracts. Assist with label development and review for compliance
before release.
• Submit and review change controls to determine the level of change and consequent submission requirements. Analyze the
input of cumulative product changes to current product submissions.
• Contribute to the development and functioning of the crisis/ issue management program. Ensure product safety issues and
product-associated events are reported to regulatory agencies. Provide regulatory input for product recalls and recall
communications Job specific responsibilities may include (choose applicable areas and expand as appropriate).
• Medical writing, Advertising and promotion, Labeling, Controlled substances (e.g. DEA), Restricted substances (e.g.
REACH), Compendial / standards, Import / export, Country specific regulatory support.
Communicate effectively verbally and in writing.
Communicate with diverse audiences and personnel.
Required Qualifications
Major/Field of Study Or Education Level
Bachelors Degree (± 16 years) Related field. ☒ an equivalent combination of education and work experience
Preferred Qualifications:
Masters Degree (± 18 years) In Regulatory Affairs preferred and may be used in lieu of direct regulatory experience.
Experience/Background
Minimum 3 years' experience in similar area.
3-or more years of experience in a regulated industry (e.g., medical products, nutritionals). 2 or more years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Knowledge of: Regulatory history, guidelines, policies, standards, practices, requirements and precedents.
````````GxPs (GCPs, GLPs, GMPs).
Preferred Qualifications:
Principles and requirements of promotion, advertising and labeling.
Write and edit technical documents
Work with cross-functional teams.
Work with people from various disciplines and cultures.
Negotiate internally and externally with regulatory agencies.
Pay strong attention to detail.
Manage projects.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
The base pay for this position is
$75,300.00 – $150,700.00In specific locations, the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf