Specialist III, Product Risk

Recruiter: Francisco Munoz Munoz

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

This is a highly dynamic role in which you will work in a team environment to help develop global evidence-based clinical strategies for electrophysiology medical devices (EP) 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 electrophysiology 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. 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 contribute to development of prospective evidence strategy 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.
• Aid in the development and execution of strategies for regulatory responses for regulatory submissions

Minimum Qualifications

• Bachelor’s, Master’s or Advanced degree (PhD, research-based MS, MD, RN, DVM) in a scientific, medical, or engineering field.
• 4+ years professional experience in a scientific, engineering, medical, or medical device space.

• 2+ years of experience in at least one of the following areas:

• Developing Clinical Evaluation and Post-Market Clinical Follow-Up Plans/Reports in compliance with EU MDR 2017/745, MDCG guidance, and harmonized standards.

• • Clinical treatment and management of patients undergoing EP therapies, including radiofrequency ablation, cryoablation, or pulsed field ablation.

• Experience in the medical device industry, with understanding of regulatory requirements for EU MDR, FDA, and global submissions.
• Understanding different types of clinical evidence (e.g., literature, clinical trials, real-world evidence, etc.) and the benefits and limitations of each type of data.
• Analytical skills, including familiarity with medical literature.
• Medical/scientific writing skills.
• Advanced proficiency in English aligned with C1 level or 85-90% proficiency.

Preferred Qualification

• 2+ years of professional experience in multiple of the areas identified above.
• Knowledge of electrophysiology medical device products and related disease states/ medical terminology.
• Experience 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.

#CRTA #CRGH 

Requisition ID: 618715

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!

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, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.