Job Description

Additional Locations: Ireland-Galway; 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, were solving some of the most important healthcare industry challenges. Together, were one global team committed to making a difference in peoples lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your lifes work.

About this role:

This is a highly dynamic role in which you will work in a team environment to develop global evidence-based clinical strategies for interventional cardiology medical devices by creating 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 and leadership 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 submissions

What were looking for in you:

Minimum Qualifications

* Bachelors/Masters 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
* 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 youre looking to truly make a difference to people both around the world and around the corner, theres 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: 474627