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 103,000 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.
WHAT YOU"LL DO:
The Director of Regulatory Affairs, Cardiac leadership role’s
main responsibility is to combine knowledge of scientific,
regulatory and business issues to enable products that are
developed, manufactured or distributed to meet required
legislation. The incumbent has division level influence and is
generally considered a key opinion leader and an expert resource
both within Abbott and externally; he/she has an opportunity to
influence changing regulations and guidance, interface with outside
regulatory agencies and trade associations and provide executive
management with regulatory metrics/information; he/she may plan,
direct, coordinate and control the regulatory affairs activities
related to Abbott Diagnostics products worldwide.
Main responsibilities for the Director of Regulatory Affairs,
Responsible for compliance with applicable Corporate and
Divisional Policies and procedures.
Develop and advance the organization’s policy and procedures for
regulatory affairs and compliance to establish a compliant
Anticipate regulatory and related obstacles and emerging issues
throughout the product life-cycle.
Analyze and compare regulatory outcomes with initial product
concepts and recommend future strategies and actions.
Develop global regulatory strategies and update based upon
Create and develop product positioning strategies based upon
Participate in applicable trade association/industry working
groups to influence policy/rule-making in alignment with business
Negotiate with regulatory authorities during the development and
review process to ensure submission approval.
Provide strategic input and technical guidance on regulatory
requirements to development teams. Ensure pre=approval compliance
activities are completed.
Develops, communicates, and builds consensus for operating goals
that are in alignment with the division and corporation.
Interfaces with a variety of management levels including senior
management on significant matters, often requiring the coordination
of activity across organizational units.
Creates mid- to long-range plans to carry out objectives
established by top management.
Develops and calculates a budget for one or more departments to
meet organizational goals.
Forecasts future departmental or group needs including human and
material resources and capital expenditures.
Assignments are expressed in the form of objectives.
EDUCATION AND EXPERIENCE YOU’LL BRING:
Bachelor’s Degree (+ 16 years) in science (biology, chemistry,
microbiology, immunology, medical technology, pharmacy,
pharmacology), math, engineering, or medical fields is
MS in a technical area or MBA is preferred; a PhD in technical
area or law is helpful but not required
Certification is a plus (such as RAC from the Regulatory Affairs
7-10 years of experience in a regulated industry required, for
example medical devices, diagnostics, nutritionals; experience in
in-vitro diagnostics (IVD) strongly preferred
7-10 years of experience in regulatory preferred but may
consider quality assurance, research and development/support,
scientific affairs, operations, or related area.
Minimum 3 years direct management experience
Extensive experience directing US regulatory strategy
Significant experience interacting and negotiating with the FDA,
specifically the Division of Chemistry and Toxicology Devices
within OHT7 of CDRH
At Abbott, you can have a good job that can grow into a great
career. We offer:
A fast-paced work environment where your safety is our priority
(Include for Manufacturing roles only)
Production areas that are clean, well-lit and
temperature-controlled (Include for Manufacturing roles only)
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
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.
Get tailored job recommendations based on your interests. The
individual will provide strategic direction and technical guidance
on regulatory requirements to a variety of Abbott’s development
teams driving premarket strategies that lead to robust
JOB ID: 30953579
LOCATION United States - Illinois - Lake Forest
DIVISION ADD Diagnostics
TRAVEL Yes, 25 % of the Time
MEDICAL SURVEILLANCE No
SIGNIFICANT WORK ACTIVITIES Continuous sitting for prolonged
periods (more than 2 consecutive hours in an 8 hour day)
Our business encompasses many different functions and
capabilities, which allows you to explore careers in various
GROWTH PLANNING Growth Planning and Performance Excellence is an
annual process through which you'll be able to have open career
discussions with your manager to help you determine your own career
path and future.
TRAINING & NETWORKS We provide a wide range of classroom and
e-learning courses to help you develop new skills and enhance your
WE'RE RECOGNIZED AROUND THE WORLD DOW JONES SUSTAINABILITY INDEX
BEST CORPORATE CITIZENS FORTUNE CHANGE ???????THE WORLD FORTUNE'S
MOST ADMIRED COMPANIES JOIN OUR TALENT COMMUNITY We will notify you
about relevant positions, and keep you in mind whenever we have
Abbott welcomes and encourages diversity in our workforce
including Minorities, Women, Individuals with Disabilities and
Protected Veterans. We provide reasonable accommodation to
qualified individuals with disabilities.
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trademark, trade name, or trade dress in this site may be made
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