Clinical Research and Development Advisor

1 week ago


Santa Clara, California, United States Abbott Laboratories Full time
About Abbott Laboratories

Abbott Laboratories 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.

Job Title: Principal Clinical R&D Advisor

We are seeking a highly skilled Principal Clinical R&D Advisor to join our team at Abbott Laboratories. As a key member of our clinical research and development team, you will be responsible for providing clinical knowledge, expertise, and direction relevant to manufacturing, quality, performance, and patient safety during all phases of development of a product or concept.

Key Responsibilities:
  • Support product development by contributing clinical knowledge to bench testing, performing in-vitro and/or in-vivo device evaluations, and assisting in the development of new test methods.
  • Create clinical performance evaluation plans to assess physician acceptance and the expected performance of new products.
  • Write device Instructions For Use (IFU).
  • Participate in the Risk Analysis process for new or improved devices to ensure that potential risks to patients associated with use of the device are identified and appropriately analyzed.
  • Participate in the Product Action process by performing and documenting a Health Hazard Assessment and communicating the assessment to Quality Assurance.
  • Contribute clinical perspective to the decision-making process regarding product recall or field action.
Requirements:
  • Bachelor's degree in a relevant field.
  • 7 years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience.
  • Strong understanding and application of business concepts, procedures, and practices.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
Preferred Qualifications:
  • RT, RN, or RCIS certification or degree.
  • 4-5 years of recent catheter lab experience (coronary + endovascular ideal).
  • Solid understanding and application of business concepts, procedures, and practices.
About the Role

This is an exciting opportunity to join a dynamic team at Abbott Laboratories and contribute to the development of innovative medical devices. As a Principal Clinical R&D Advisor, you will have the opportunity to work on a wide range of projects, from product development to clinical trials, and collaborate with cross-functional teams to bring new products to market.

Abbott Laboratories is an Equal Opportunity Employer, committed to employee diversity. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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