Additional Locations: Ireland-Galway; US-CA-Valencia; US-MA-Marlborough; US-MN-Maple Grove

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

About this role:

This is a highly dynamic role in which you will work in a team environment to develop clinical documentation that systematically synthesizes information from multiple data sources. As a Clinical Evaluation Scientist, you will plan and develop 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. This role applies analytical thought processes and a highly methodical clinical evaluation approach to develop benefit/risk profiles for the Boston Scientific portfolio interventional cardiology devices. A successful candidate 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:

• 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.
• Create analyses to evaluate product benefit/risk profile and safety and performance and develop profile of adverse events. Identify potential clinical evidence gaps and contribute to development of prospective evidence strategies to address gaps.
• Ensure alignment of clinical data with risk documentation, and to contribute to product labeling.
• Aid in the development of regulatory responses for regulatory submissions

What we’re looking for in you: 

Minimum Qualifications

• Bachelor’s/Master’s degree and 3+ years professional experience or Advanced degree (PhD, research-based MS, MD, RN/DVM)
• Analytical skills, including strong familiarity with scientific literature
• Strong medical/scientific writing skills

Preferred Qualification

• Knowledge of interventional cardiology/structural heart products and related disease states/ medical terminology
• Medical device experience, including understanding of regulatory
• Ability to understand engineering documentation, including risk documentation

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

Requisition ID: 474626