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Principal Clinical Scientist - EUMDR

Company: Abbott Laboratories
Location: Plymouth
Posted on: September 15, 2020

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 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. Principal Clinical Scientist - EUMDR

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.

JOB DESCRIPTION:

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 medical device.

* 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 programs.

EDUCATION AND EXPERIENCE YOU'LL BRING

Required

* 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 devices.

* 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 functions.

* Experienced in working in a quality system environment.

Preferred

* Advanced degree preferred.

* Degree in the sciences, medicine, or similar discipline highly preferred.

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.

JOB FAMILY:

Clinical Affairs / Statistics

DIVISION:

SH Structural Heart

LOCATION:

United States > Minnesota > Plymouth : 5050 Nathan Lane N

ADDITIONAL LOCATIONS:

United States > Minnesota> St. Paul > Woodridge : 177 East County Rd B

WORK SHIFT:

Standard

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)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

United States - Minnesota - Plymouth

United States - Minnesota - St. Paul * 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 devices.

* 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 functions.

* Experienced in working in a quality system environment.

Preferred

* Advanced degree preferred.

* Degree in the sciences, medicine, or similar discipline highly preferred. 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., 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)

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal., United States > Minnesota > Plymouth : 5050 Nathan Lane N

ADDITIONAL LOCATIONS:

United States > Minnesota> St. Paul > Woodridge : 177 East County Rd B, EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Keywords: Abbott Laboratories, Plymouth , Principal Clinical Scientist - EUMDR, Other , Plymouth, Massachusetts

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