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.
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
The Opportunity
Abbott is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead global regulatory initiatives. This role will drive regulatory strategy, ensure compliance, and support product development and commercialization efforts.
What You’ll Work On
- Develop and implement global regulatory strategies for new product development and lifecycle management
- Lead preparation and submission of regulatory filings (e.g., 510(k), PMA, IDE)
- Provide regulatory guidance to cross-functional teams including R&D, Clinical, Quality, and Marketing
- Monitor regulatory trends and assess impact on business strategy
- Ensure compliance with applicable regulations and standards across global markets
- Mentor and lead a high-performing regulatory team
- Collaborate with internal and external stakeholders to support regulatory advocacy and policy shaping, including interactions with health authorities such as the FDA
Required Qualifications
- Advanced degree in life sciences, engineering, or related field (MS, PhD, PharmD, or MD)
- 10+ years of regulatory affairs experience in the medical device, diagnostics, nutrition, or pharmaceutical industry
- Extensive experience working with the FDA
- Previous experience as an FDA employee is highly desirable
- Experience in a global, matrixed organization
- Proven success in leading regulatory submissions and obtaining approvals
- Familiarity with international regulatory frameworks such as EU MDR
- Excellent leadership, communication, and strategic planning skills
This is a pipeline opportunity and not an active job posting.
APPLY NOW
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.comFollow 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 and @AbbottGlobalThe base pay for this position is $188,700.00 – $377,300.00. In specific locations, the pay range may vary from the range posted.
