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Principal Clinical Scientist - EUMDR job in Plymouth at Abbott Laboratories

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Principal Clinical Scientist - EUMDR at Abbott Laboratories

Principal Clinical Scientist - EUMDR

Abbott Laboratories Plymouth, MN Full Time
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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.

Principal Clinical Scientist

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.

We have an exciting opportunity for the right candidate to join our rapidly growing clinical team within the Abbott Structural Heart medical device business unit. 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. He/she will lead the identification of EUMDR clinical evidence requirements for Structural Heart products, and work with 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.

WHAT YOU’LL DO 

  • 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.

  • Ensure PMCF plans and reports are in alignment with the product’s overall post-market surveillance plan.  

  • Identify potential PMCF gaps and provide strategies to mitigate the gaps. 

  • Identify opportunities and work with cross-functional partners to establish processes that assess alternative clinical data sources to support the clinical evidence needs for a given product.

  • Interact with regulatory agencies, as needed, and use scientific and medical knowledge to review or author responses and/or provide guidance to questions from regulatory bodies.

  • Design and/or provide input into clinical studies in collaboration with internal stake holders including clinical project management, clinical operations, clinical science, biostatistics data management, regulatory affairs, medical affairs as well as external stake holders including steering committees, and national principal investigators (if applicable).

EDUCATION AND EXPERIENCE YOU’LL BRING 

Required 

  • Bachelor's degree required, advanced degree preferred. Degree in the sciences, medicine, or similar discipline highly preferred.

  • 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.

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:  [ Link removed ] - Click here to apply to Principal Clinical Scientist - EUMDR  

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 [ Link removed ] - Click here to apply to Principal Clinical Scientist - EUMDR, on Facebook at [ Link removed ] - Click here to apply to Principal Clinical Scientist - EUMDR and on Twitter @AbbottNews and @AbbottGlobal

 

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