Medical and Clinical Affairs United States - Minnesota -
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.
Our business purpose is to restore health and improve quality of
life through the design and provision of device and management
solutions for the treatment of structural heart disease. We aim to
lead the markets we serve by requiring the solutions we offer
customers provide an improved benefit/risk profile as compared to
existing standards of care; a performance threshold that by
definition, guides and ensures the productive output of our
engineering, business development, and clinical research efforts
result in outcomes that advance the standard of care.
Our location in Plymouth, MN is looking for a Principal Clinical
Scientist – EUMDR.
WHAT YOU’LL DO
The Principal Clinical Scientist will establish and review the
European Union Medical Device Regulation (EUMDR) clinical evidence
strategies to support the Structural Heart clinical products
throughout their lifetime.
Work with a cross-functional team comprising of clinical program
directors, clinical scientists, global data scientists,
biostatisticians, medical directors, regulatory affairs
specialists, and other cross-functional team members
to collaboratively develop and execute the clinical strategies
to satisfy the EUMDR evidence generation requirements.
Be a subject matter expert for the EUMDR regulation and guidance
as they pertain to clinical evidence generation requirements to
support the safety and performance throughout the lifetime of a
Provide guidance on clinical evidence strategies, in alignment
with EUMDR regulations, throughout a products lifetime.
Review clinical portfolio to ensure EUMDR post-market clinical
follow-up (PMCF) strategies are adequate and consistently applied
throughout the product lifetime following CE Mark across various
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelor's degree required.
Minimum of 8+years of related work experience with a complete
understanding of specified functional area, or an equivalent
combination of education and work experience
Possesses working knowledge of EU MDR Clinical evidence
requirements and a mix of working with Class I, II and III
Experienced with clinical studies design and execution in the
European regulatory environment.
Experienced in project management and leading projects from
initiation to completion
Is recognized as an expert in work group and across
Experienced in working in a quality system environment.
Advanced degree preferred.
Degree in the sciences, medicine, or similar discipline highly
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
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. JOB
LOCATION United States - Minnesota - Plymouth
ADDITIONAL LOCATION United States - Minnesota - St. Paul
DIVISION SH Structural Heart
TRAVEL Yes, 10 % of the Time
MEDICAL SURVEILLANCE Yes
SIGNIFICANT WORK ACTIVITIES Continuous sitting for prolonged
periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
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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