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Senior Director, Medical Affairs (Abbott Structural Heart)
Abbott
Application
Details
Posted: 10-Oct-25
Location: North Chicago, Illinois
Type: Full Time
Categories:
Physicians/Surgeons
Physicians: Specialty
Sector:
Private Industry
Additional Information:
Hybrid/Remote is allowed.
Internal Number: 31126987
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 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
We are seeking a highly experienced and strategic Senior Director of Medical Affairs to lead medical and scientific initiatives across our platforms for Heart Valve Therapy (TAVI, TMTI, and Cardiac Surgery) and treatment of Congenital Heart Disease (ASD, VSD and PDA closure). This role is critical in shaping clinical development strategies, guiding regulatory submissions, and supporting cross-functional teams to ensure the safe and effective use of our products.
What You'll Work On
Serve as a subject matter expert in heart valve and congenital heart therapies maintaining current knowledge of standards of care and relevant medical literature to support internal and external inquiries.
Collaborate with R&D, manufacturing, and quality teams to integrate product lifecycle insights into clinical trials; align clinical strategies with commercial objectives.
Engage with external Key Opinion Leaders (KOLs) to guide treatment protocols and clinical development.
Provide medical and scientific leadership in preparing global regulatory submissions and representing the company in regulatory meetings.
Lead the design and approval of clinical strategies, trial protocols, investigator brochures, and study reports.
Oversee internal medical monitoring processes, including adverse event reporting and clinical event committees, in partnership with Clinical Affairs and Product Performance.
Partner with product development and marketing to define clinical requirements and review promotional and training materials for scientific accuracy and compliance.
Investigate product complaints with clinical impact and support post-market surveillance.
Author and review internal and external literature, white papers, and Medical Affairs Information responses.
Ensure compliance with FDA and global regulatory standards, and maintain collaborative communication across teams, customers, and vendors.
Strategic Program Involvement
You will also play a key role in the implementation and expansion of the Structural Heart valve platforms. Your strategic contributions may include:
Participating in the processes for Investigator Sponsored Studies, Educational and Fellowship Grants, Medical Advisory Board, and Product Complaints.
Providing input to R&D, QA, Regulatory Affairs, and Clinical Affairs.
Participating in proctor meetings, Medical Advisory Boards, and product summits.
Engaging with customers on device efficacy, safety, and future product development needs.
Training and supporting U.S. clinical field specialists.
Proctoring new U.S. sites and providing ongoing case support.
Qualifications
Medical degree (M.D.) required; post-graduate degrees preferred.
10+ years as an interventional cardiologist or relevant experience, familiar with TAVI / MitraClip / TriClip.
Strong knowledge of cardiovascular anatomy, physiology, pharmacology, and device interactions.
Experience in medical device development and clinical trial design.
Skilled in medical monitoring, adverse event reporting, and oversight of clinical events committees.
Proficient in medical writing and review of promotional, training, and scientific materials.
Ability to assess product complaints and contribute to post-market surveillance.
Collaborative experience in matrixed, cross-functional environments (R&D, Regulatory, Clinical, Marketing).
Excellent communication, leadership, and multitasking skills in fast-paced settings.
Company Overview
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.
Company History
For more than 130 years, we've put science and innovation to work – to create more possibilities for more people through the power of health. We adapt and respond quickly to changes in the world around us to deliver better solutions to help people live their best lives.
Notable Products / Brands
FreeStyle Libre, MitraClip, BinaxNow, ID Now, Ensure, Similac, Pedilyte, Pediasure, Alinity, i-STAT, Brufen
Notable Accomplishments / Recognition
- Fortune’s “Most Admired Companies” since 1984; #1 in Medical Products for the past 7 years
- Dow Jones Sustainability Index since 2005; Industry Group Leader for the past 7 years
- Fortune’s “Best Big Companies to Work For”
- 100 Best Companies,” Working Mother magazine
- Top 20 Employer,” Science magazine
- DiversityInc “Top 50 Companies for Diversity”