Boston Scientific Clinical Evaluation Scientist III 

United States, Massachusetts, Marlborough 

893385303

US-MN-Arden Hills; US-MN-Maple Grove

This is a highly dynamic role in which you will work in a team environment to ensure our products are safe for patients, and work as intended, by systematically analyzing data from multiple data sources. This role applies analytical thought processes and a highly methodical clinical evaluation approach to support benefit/risk profiles for the Boston Scientific portfolio interventional cardiology devices. A successful candidate is highly organized, has excellent writing skills as well as the ability to work collaboratively with cross-functional partners. Your efforts support product approval, indication expansion and claim support, and mandated post-market requirements.

Your responsibilities will include:

• Support development of clinical evaluation reports (CERs) and post-market clinical follow-up (PMCF) reports, as well as summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards and business needs.
• Compile, appraise, and evaluate data from multiple sources including clinical trials, medical literature, design verification/validation data, and product complaint data. Includes development of literature search strategies and methodical evaluation of medical literature.
• Support analyses to evaluate product benefit/risk profile and safety and performance and develop profile of adverse events.
• Ensure alignment of clinical data with risk documentation, and to contribute to product labeling.
• Support the development of regulatory responses for regulatory submissions

Required qualifications:

• Minimum of a bachelor’s degree
• Minimum of 4 years scientific writing experience specifically in writing of CERs
• Analytical skills, including strong familiarity with scientific literature
• Strong medical/scientific writing skills

Preferred qualifications:

• Advanced degree (PhD, research-based MS, MD, RN/DVM)
• Knowledge of interventional cardiology and related disease states/ medical terminology
• Medical device industry experience
• Experience writing clinical evaluation reports

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.