Associate Director Regulatory Affairs - Global Regulatory Services

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.
• 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 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.

In Abbott’s Global Regulatory Services (GRS) division, we’re helping people to have access our life-changing technologies and products by providing strategic and predictable Regulatory Services in collaboration with the medical device business units that Leveraged Services team supports. 

The Opportunity

The Associate Director Regulatory Affairs will work for our Global Regulatory Services division within Leveraged Services. As an Associate Director, the individual is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.  This new team member will support key digital health technology activities (i.e., software, cybersecurity, telehealth, digital solutions, etc.) and be recognized as an expert and resource within the division.  The individual should have a strong understanding of the software lifecycle management and software development, including design, validation, and maintenance in the device regulatory environment.  Demonstrates ability to interpret and apply regulatory requirements to software systems, including documentation, risk management, and compliance strategies.  Assists management and leadership on regulatory activities and works with the medical device business units that Leverage Services team supports, including the execution of strategic regulatory initiatives, regulatory submissions, agency relationship and evaluation of regulatory policies.  The individual will apply strong communication skills, strategic thinking, and leadership experience to support the medical device business units with their regulatory submissions.  Collaborates closely with internal regulatory colleagues to ensure project strategies and regulatory submissions meet global requirements, drawing on sound knowledge of medical device regulations and experience such as from the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH).  This Associate Director Regulatory Affairs may analyze broad scope implications of changing regulations, guidance, or regulatory shifts. Additionally, may identify data needed, obtain this data, and ensure that the information is effectively shared across the medical device businesses.

What You’ll Work On

• Review regulatory submissions involving software components (e.g., 510(k), PMAs, CE marking, technical files).
• Collaborate closely with internal regulatory colleagues to ensure project strategies and regulatory submissions meet global requirements
• Develops regulatory strategies with the medical device business units for new products or changing existing products especially with FDA
• Supports and provide critical review of key documents necessary for regulatory submissions for new products or changes to existing products.
• Ensure that regulatory submissions that contain digital health technologies (i.e., software, cybersecurity, telehealth, etc.) have targeted mitigations to align with FDA expectations, ensuring high-quality sub