Senior Clinical Evaluation Scientist/Project Manager

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott  

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:  

• Career development with an international company where you can grow the career you dream of.  

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.  

• An excellent retirement savings plan with high employer contribution · Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.  

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.  

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. 
   

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.   

 

The Opportunity 

The primary function of a SENIOR CLINICAL EVALUATION SCIENTIST/PROJECT MANAGER is to combine understanding of scientific and research methodology, medical device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, MDCG Guidance documents, and EU MDR 2017/745. This role will support the Vascular product lines. 

WHAT YOU’LL DO 

• Manage, provide guidance, and oversight of CER Medical Writers’ development of Clinical Evaluation Reports and associated documents; set deliverables and project timelines and ensure timelines are met. 

• Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers). 

• Review, edit, and write portions, as needed, of Clinical Evaluation Reports and associated documents. 

• Draft and/or lead the development of regulatory responses for Notified Body and regulators’ questions upon review of submissions. 

• Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, to new produ