Additional Locations: US-MN-Maple Grove, RemoteDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High PerformanceAt 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 this role:
This is a highly dynamic role in our Interventional Cardiology division in which you will work in a team environment to develop clinical documentation that systematically synthesizes information from multiple data sources strategies for interventional cardiology medical devices. 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, with a focus on transcatheter aortic valve implantation (TAVI). A successful candidate enjoys synthesizing high volumes of medical literature, has excellent writing skills, and works 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 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.Develop and execute strategies for regulatory responses for regulatory submissionsMinimum QualificationsBachelor's degree and 5+ years professional experience 2+ years of experience planning and developing CERs Analytical skills, including ability to efficiently and effectively review and synthesize medical literatureMedical/scientific writing skillsExperience with Microsoft Word and ExcelPreferred QualificationsAdvanced degree (PhD, research-based MS, MD, RN/DVM)Knowledge of interventional cardiology/structural heart products (in particular, TAVI) and related disease states/ medical terminologyAbility to understand engineering documentation, including risk documentation Requisition ID: 491136As 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!At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.