Additional Locations: US-CA-Valencia; US-CO-Denver; US-GA-Atlanta; US-IL-Chicago; US-KS-Kansas City; US-MA-Marlborough; US-MI-Detroit; US-MN-Maple Grove; US-NY-New York City; US-PA-Philadelphia; US-TX-Houston; US-WA-Seattle; US-WI-Madison
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 help develop global evidence-based clinical strategies for interventional cardiology medical devices by creating 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 of interventional cardiology devices. A successful candidate has excellent writing skills as well as the ability to work collaboratively with cross-functional partners. Your efforts and leadership support product approval, indication expansion and claim support, as well as 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 using safety and performance data.
- Identify potential clinical evidence gaps.
- Collaborate with leadership and cross-functional partners to develop global clinical strategies for new product development and/or EU MDR certification to ensure alignment of clinical data with risk documentation and contribute to product labeling.
- Develop and executes strategies for regulatory responses for regulatory submissions
What we're looking for in you:
- Bachelor's degree in Science/Engineering
- 9+ years professional experience
- Analytical skills, including ability to efficiently and effectively review and synthesize medical literature
- Medical/scientific writing skills
- Ability communicate effectively with cross-functional teams and regulatory bodies
- Advanced degree (RN/DVM, MD, and/or PhD) with 7+ years of professional experience
- Knowledge of interventional cardiology/structural heart products and related disease states/ medical terminology
- Medical device experience, including understanding of regulatory and quality systems
- Ability to understand engineering documentation, including product risk documentation
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: 465877