Associate Director, Regulatory Affairs, LAC

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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.

ABOUT ABBOTT DIAGNOSTICS:

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott's life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations - with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

Abbott Core Diagnostics currently has an opportunity for an Associate Director, Regulatory Affairs, LAC to be based in Lake County, Illinois, USA; Mexico; Colombia or Brazil.

WHAT YOU'LL DO

As a regulatory leader that provides direction and supervision to regulatory affairs staff, the function of the Associate Director, Regulatory Affairs, LAC within Core Diagnostics is to combine knowledge of scientific, regulatory, Quality Systemand business issues to enable products that are developed, manufactured or distributed to meet worldwide regulatory requirements. The individual has cross-department level influence and is generally recognized as an expert resource both within Abbott and externally.

RESPONSIBILITIES:
  • Provides leadership to develop and execute regional regulatory intelligence strategies that include emerging regulations, regulatory authority/institution updates, regulatory advocacy and trade association interactions.
  • With cross-functional partner, define and oversee the standardization and implementation of systems/processes/communications to monitor the regulatory environment for changes that may have an impact on business products and goals.
  • Drive and support the decision-making process to understand and prioritize the regulatory risks and opportunities regionally including frequent communication to various internal management stakeholders of regulatory strategies and internal impact analyses.
  • Remains current on developments in field(s) of expertise, emerging regulatory requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory submissions and Quality Systems. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.
  • Directs process for implementing new regulations and standards into the Quality System.
  • Review of product, manufacturing and facility changes for compliance with applicable regulations (Change Control). Ensures compliance with product post marketing approval requirements.
  • Identifies need for new regulatory policies, processes and SOPs.
  • Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), and other regulatory requirements.
  • Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.


EDUCATION AND EXPERIENCE YOU'LL BRING

Required
  • Bachelors degree (or equivalent); Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
  • M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
  • 5-7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
  • 5-7 years experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.


Preferred
  • Fluent in Spanish
  • Regulatory Affairs experience in diagnostics or medical devices
  • Knowledge of IVD Blood Screening or Diagnostics products
  • Experience in Quality systems
  • Ability to work in a highly-matrixed and geographically diverse business environment.
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment.


WHAT WE OFFER
  • At Abbott, you can have a good job that can grow into a great career. We offer:
  • Training and career development , with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities


Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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 @AbbottGlobal.

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