Senior Specialist Regulatory Affairs

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 .

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Des Plaines, IL location in the Abott Molecular Division. Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level.

What You’ll Work On

As a Senior Regulatory Affairs Specialist, you’ll support the regulatory department to ensure business processes are efficient and compliant. You’ll work with different business functions; help gather and present data for product registration worldwide and prepare or oversee the preparation of necessary documentation. This is an individual contributor role.

Areas you will work on if hired:

• Regulatory Compliance: Understand and apply regulatory requirements, and prepare and submit regulatory documents.

• Documentation: Compile, review, and submit necessary paperwork for product registration.

• Knowledge: Stay informed about regulatory guidelines, policies, and standards.

• Agency Interaction: Know the structure and processes of regulatory agencies.

• Product Laws: Understand laws related to products, promotion, advertising, and labeling.

• Guidelines: Follow domestic and international regulatory guidelines, including Quality System Regulation 21CFR 820 and IVDR (EU) 2017/746.

Skills Needed:

• Project Management: Create project plans and timelines and manage complex information.

• Analytical Thinking: Think critically and make informed decisions.

• Technical Knowledge: Understand various technical options and their business impact.

• Ethical Judgment: Make ethical decisions within policy and regulations.

• Business Acumen: Understand business functions and relationships.

• Regulatory Strategy: Help define regulatory strategies and solve issues.

• Communication: Work with different management levels and coordinate activities.

• Leadership: Train others, lead projects, and provide technical guidance.

Required Qualifications

• Bachelor's degree (or equivalent) Science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.

• 3+ years of experience in similar role in a regulated industry

Preferred Qualifications

• PMA (Premarket Approval) experience for US

• MDR/IVDR experience for EU

• Health Canada and WHO experience is ideal

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: