Associate Manager Clinical Evaluation Scientist

Additional Locations: Costa Rica-Heredia

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.

Hybrid Roles:

Boston Scientific's hybrid workplace includes Working From Home and onsite. You will have the opportunity to discuss details in the interview. 

About the role

This is a highly dynamic leadership role in which you will oversee and support a team responsible for clinical evaluation and risk documentation activities for the Electrophysiology (EP) Solutions portfolio. You will help develop global evidence-based clinical strategies for EP medical devices by creating and supervising the creation of clinical documentation that systematically synthesizes information from multiple data sources.

As an Associate Manager Clinical Evaluation Scientist, you will plan, review, and develop clinical evaluation reports (CERs), post-market clinical follow-up (PMCF) reports, and summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards. This role requires 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. You will also mentor and oversee the work of entry level Clinical Evaluation Scientists and interns as needed, support resource allocation, and ensure high-quality outputs that support product approval, recertification, and post-market requirements.

Your responsibilities include:

• Support execution by coordinating assignments for entry-level Clinical Evaluation Scientists, onboarding interns as needed, managing training logistics, and contributing to their professional development.
• Supervise and support contractors in the development of CER projects, ensuring compliance with Regulation (EU) 2017/745 of the European Parliament (EU MDR), U.S. Food & Drug Administration Code of Federal Regulation requirements, and other applicable regulatory requirements.
• Oversee EP core sustaining activities, including design changes, risk management, end-of-life (EOL) planning, EU MDR recertification, preparation for audits, and assessment of PMCF data gaps.
• Provide leadership support and serve as backup for EP team meetings, ensuring alignment across the team and continuity of operations.
• Coordinate and, when needed, perform the compilation, appraisal, and evaluation of data from multiple sources — including clinical trials, medical literature, design verification/validation data, and product complaint data — ensuring alignment with risk documentation to identify gaps or emerging concerns.
• Oversee and, as appropriate, conduct literature search strategies in collaboration with librarians, including systematic evaluation of medical literature through screening, appraisal, and data extraction.
• Guide and, when required, carry out analyses to evaluate product benefit/risk profile, safety, and performance; develop adverse event profiles; and identify clinical evidence gaps, contributing to strategies that address these gaps.
• Collaborate with leadership and cross-functional partners to align clinical data with risk documentation for design changes, EU MDR certification, and contribute to product labeling.
• Manage ongoing design and quality activities to support device changes or improvements, assess impacts on existing clinical data strategies, propose new evidence-generation activities, and coordinate with management to ensure resourcing needs are met.

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

Required Qualifications:

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.

• 3+ 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.
  • Preparing, managing, and submitting Regulatory Technical Documentation in accordance with EU MDR 2017/745 to support device market access in the EU.
• Demonstrated leadership or supervisory experience, including mentoring or managing junior staff or contractors.

• 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 Qualification

• 3+ years of professional experience in multiple of the areas identified above.
• Knowledge of electrophysiology medical device products and related disease states/ medical terminology.
• Experience in the medical device industry, with understanding of regulatory requirements for EU MDR, FDA, and global submissions.
• 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.

Requisition ID: 614635

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.