Boston Scientific Senior Product Risk 

Costa Rica 

586797521

Hybrid Roles:

This is a highly dynamic role in which you will work in a team environment to develop global evidence-based clinical strategies for cardiology medical devices (Cardiac Rhythm Management) 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 cardiology devices. A successful candidate has excellent writing skills as well as the ability to work 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. Compare and align this data with Risk Documentation and product labeling to identify gaps or emergent concerns.

• Develop literature search strategies in collaboration with librarians and perform methodical evaluation of medical literature including screening, appraisal and extraction of relevant data.

• Develop Clinical Benefit Statements in collaboration with medical experts and develop pre- and post-market data collection strategies to support the developed statements.

• Create analyses to evaluate product benefit/risk profile, safety (e.g., develop a profile of adverse events), and performance. Identify potential clinical evidence gaps and contribute to development of prospective evidence strategy to address gaps.

• Develop global clinical data strategies in collaboration with leadership and cross-functional partners to support market access for New Product Development, Sustaining Product compliance and Design Changes to existing products.

• Manage ongoing Design and Quality activities to support necessary changes and/or improvements to devices, including assessing the impact to existing clinical data strategies, proposing and developing new clinical data activities to meet any identified gaps, and coordinating with management to ensure resourcing needs are considered.

• Aid in the development and execution of strategies for responses for regulatory submissions.

What we’re looking for in you:

Minimum Qualifications

• Bachelor’s, Master’s or Advanced degree (PhD, research-based MS, MD, RN, DVM) in a scientific, medical, or engineering field.

• 6+ years professional experience in a scientific, engineering, medical, or medical device space with 3+ years of experience in at least one of the following:

• Writing and Developing Clinical Evaluation Plans/Reports and Post-Market Clinical Follow-Up Plans/Reports in accordance with Regulation (EU) 2017/745 of the European Parliament (i.e., EU Medical Device Regulations), relevant Medical Device Coordination Group (MDCG) guidance, and harmonized standards

• Working in the clinical treatment and management of patients receiving Cardiac Rhythm Therapies, including but not limited to:

• Pacemakers;

• Implantable Cardioverter-Defibrillators (ICDs);

• Cardiac Resynchronization Therapy Pacemakers/Defibrillators (CRT-P/Ds); or

• Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs).

• Writing, Developing, Managing, and Submitting Regulatory Technical Documentation submissions in accordance with Regulation (EU) 2017/745 of the European Parliament (i.e., EU Medical Device Regulations) to support EU Market access of Cardiac Rhythm Devices

• Thorough understanding of different types of clinical evidence (e.g., literature, clinical trials, real-world evidence, etc.) and the benefits and limitations of each type of data.

• Experience in strategically applying knowledge of regulations, medical knowledge, and data types to develop clinical data strategies to support submission.

• Analytical skills, including strong familiarity with medical literature

• Strong medical/scientific writing skills

• Advanced proficiency in English aligned with C1 level or 85-90% proficiency

Preferred Qualifications

• 3+ years of professional experience in multiple of the areas identified above

• Experience with/knowledge of with Quality Management System documentation, specifically Risk Management Documents (e.g., Hazard Analysis, Risk Management Report, Risk Management Plan)

• Experience with engineering documentation, including test protocols, test reports, and international standards .