Clinical Evaluation Scientist II

Additional Location(s):Costa Rica-Heredia; Costa Rica-Coyol; Ireland-Galway; US-MN-Arden Hills

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.

This person will need to be hybrid, 3 days a week in the office, at one of the Boston Scientific facilities in Costa Rica, Massachusetts, or Minnesota.

About the role:

As a Clinical Evaluation Scientist II, you will analyze and communicate clinical product risk throughout the project and product lifecycle, providing guidance in safety signal detection and assessment to project teams and senior management. You will ensure compliance with regulatory standards, guidelines, and corporate procedures related to safety risk management. Working collaboratively in a team environment, you will systematically review and synthesize data from published medical literature to develop clinical documentation, including CERs, PMCF reports, and SSCPs, in alignment with clinical and regulatory standards. This role requires excellent writing skills, analytical thought processes, and a methodical clinical evaluation approach to develop benefit/risk profiles for Boston Scientific's interventional cardiology devices. Your efforts will support product approval, indication expansion, claim support, and mandated post-market requirements.

Your responsibilities include:

• Identify scope and comparative information for CES/CRBA, collaborating with cross-functional partners for clinical risk analysis.
• Conduct literature searches to summarize harms, hazards, alternate therapies, and device-specific benefits; collect primary data from the Design History File.
• Generate risk management documents for BSC products to support internal and regulatory requirements.
• Serve as a liaison between Risk Management and project teams, communicating pertinent information.
• Collaborate with Clinical and R&D to develop clinical deliverable criteria and clinical trial rationalization plans; provide information for DFU, RAWB, and FMEA documents.
• Mentor and act as a subject matter expert in risk management activities, consulting on complex projects and product grouping.
• Serve as SME and Function representative in internal and external audits, preparing responses and supporting process improvements.
• Compile and evaluate data from clinical trials, medical literature, design verification/validation, and product complaints.
• Support the development of literature search strategies and methodical evaluation of medical literature.
• Create analyses to evaluate product benefit/risk profiles, safety, and performance objectives, and develop adverse event profiles.

Required qualifications:

• Minimum of a Bachelor of Science/engineering degree
• Minimum of 3 years of professional experience in clinical research
• Experience in clinical evaluation and EUMDR
• Strong analytical skills, including strong familiarity with scientific literature
• Strong medical/scientific writing skills

Preferred qualifications:

• Advanced degree (PhD, research-based MS)
• Knowledge of interventional cardiology/structural heart products and related disease states
• Medical device experience, including understanding of regulatory requirements
• Familiarity with citation management software

Requisition ID:588399

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!

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 prohibited substance freeworkplace. 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.