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Regulatory Program Director
Regulatory Program DirectorAbbott • Plano, Texas, United States
Regulatory Program Director

Regulatory Program Director

Abbott • Plano, Texas, United States
[job_card.variable_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

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 student debt program and 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 :

The Director, Regulatory Programs will join our Global Regulatory Operations team and lead portfolio management of regulatory programs across medical device business units, international regulatory teams, and global regulatory operations. This role provides strategic leadership and stewardship to ensure alignment with division strategies and business objectives.

The Director will be responsible for developing, maintaining, and reporting on timelines, budgets, and regulatory activity tracking. Additionally, they will lead initiatives aimed at improving efficiency and effectiveness within regulatory processes. By applying best practices in program management, the Director will help achieve—and exceed—medical device division goals.

This position serves as the primary point of contact for program reporting and updates to cross-business unit and division regulatory leaders.

WHAT YOU’LL WORK ON :

  • Experience in project leadership roles in a medical device, biomedical, or other regulated industry.
  • Strategic, conceptual analytical thinking and decision-making skills. Critical thinking / problem-solving skills.
  • Ability to plan and facilitate meetings. Demonstrated expertise in leading teams.
  • Ability to negotiate consensus among diverse groups and influence the activities of others not in own reporting structure.
  • Strong written and presentation skills; ability to communicate effectively with senior management.
  • Technical background sufficient to understand issues involved with the project. Understanding of the strategic and operational context of the projects; organizational savvy.
  • Demonstrated ability in managing expectations on program requirements and deliverables.
  • Personal integrity and courage to escalate issues about the project and to advocate for responsible solutions to management.
  • Adaptability and flexibility including the ability to manage deadline pressure, ambiguity and change.

    • QUALIFICATIONS :

  • Bachelor’s degree in science, math, engineering, or medical field OR an equivalent combination of education or work experience.
  • 10+ years’ relevant experience, regulatory preferred but may consider quality assurance, research and development / support, scientific affairs, operations, or related area.
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