Clinical Evaluation Scientist II - Boston Scientific : Job Details

Additional Location(s): US-MA-Marlborough; Costa Rica-Coyol; Costa Rica-Heredia; US-MA-Bedford; US-MA-Boston; US-MA-Burlington; US-MA-Cambridge; US-MA-Lexington; US-MA-Lowell; US-MA-Natick; US-MA-Quincy; US-MA-Western/Springfield; US-MA-Worcester; US-MD-Baltimore; US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Northern/Duluth; US-MN-PlymouthDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - 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 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 support benefit/risk profiles for the Boston Scientific portfolio interventional cardiology devices. A successful candidate is highly organized, has excellent writing skills, and has the ability to work collaboratively with cross-functional partners. Your efforts support product approvals and mandated post-market requirements in geographies worldwide, with a focus on the European Union.This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills or Maple Grove, MN or Marlborough, MA or Costa Rica.You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.Your responsibilities will include:Support development of 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.Support analyses to evaluate product benefit/risk profile and safety and performance and develop profile of adverse events. Ensure alignment of clinical data with risk documentation, and to contribute to product labeling.Support the development of regulatory responses for regulatory submissionsRequired qualifications:Bachelor's/Master's degree and minimum 5 years professional experience or Advanced degree (PhD, research-based MS, MD, RN/DVM) and 2 years professional experienceAnalytical skills, including strong familiarity with scientific literatureProven medical/scientific writing skillsPreferred qualifications:Ability to understand engineering documentation, including risk documentation Experience with regulatory body communicationsRSRBSCRequisition ID: 593471As 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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran's status, age, mental or physical disability, genetic information or any other protected class.Boston Scientific maintains a prohibited substance 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.Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.