Principal Clinical Evaluation Scientist

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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:
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 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 and leadership support product approval, indication expansion and claim support, and mandated post-market requirements. 

Your responsibilities will include: 

• 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. 
• 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 develop prospective evidence strategies to address gaps.
• Collaborate with leadership and cross-functional partners to develop global clinical strategies for new product development and/or EU MDR certification, ensure alignment of clinical data with risk documentation, and to contribute to product labeling.
• Integrate clinical strategy into the new product development lifecycle
• Develop and execute strategies for regulatory responses for regulatory submissions

 
Required qualifications:

• Bachelor’s/Master’s degree and 10+ years professional experience or Advanced degree (PhD, research-based MS, MD, RN/DVM) and 5+ years professional experience
• Analytical skills, including ability to efficiently and effectively review and synthesize medical literature
• Strong medical/scientific writing skills
   

Preferred qualifications:

• Ability to communicate effectively with regulatory bodies
• Experience with capital equipment, software, and/or imaging
• Medical device experience, including understanding of regulatory writing
• Ability to understand engineering documentation, including risk documentation 

Requisition ID: 553184

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!