Associate Manager, Clinical Evaluation Scientist

Additional Location(s): US-MN-Maple Grove

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.       

About the role:
Boston Scientific is seeking an experienced and strategic Associate Manager, Clinical Evaluation Scientist to lead clinical evaluation and risk documentation activities within our Electrophysiology (EP) Solutions portfolio. This highly dynamic, on-site leadership role offers the opportunity to shape clinical strategies, drive high-quality documentation practices, and support global evidence generation for life-changing medical technologies.

In this position, you will manage and mentor a team of Clinical Evaluation Scientists, oversee the development of clinical documentation—including Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) reports, and Summary of Safety and Clinical Performance (SSCP) reports—and ensure alignment with regulatory standards such as EU MDR and FDA requirements. You will collaborate cross-functionally to support product approval, indication expansion, and post-market compliance, playing a key role in developing and maintaining a strong clinical evidence base for innovative EP devices.

This is a highly visible role for a proactive leader with exceptional writing, critical thinking, and project management skills, and a passion for contributing to the advancement of electrophysiology care.

Work model, sponsorship, relocation:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include:
• Lead and coordinate assignments for entry-level Clinical Evaluation Scientists, oversee onboarding of interns, manage training logistics, and support team development.

• Supervise and guide contractors in the preparation of CERs and related documents, ensuring compliance with EU MDR 2017/745, FDA regulations, and other applicable standards.

• Oversee key EP sustaining activities including design changes, risk management documentation, end-of-life planning, EU MDR recertification, audit readiness, and PMCF data assessments.

• Provide leadership support and serve as a backup for EP team meetings to ensure operational continuity and strategic alignment.

• Direct and contribute to the evaluation of data from multiple sources (clinical studies, literature, product complaints, verification/validation data) to ensure comprehensive and aligned clinical and risk documentation.

• Oversee and, as necessary, conduct literature reviews in collaboration with research librarians, including screening, appraisal, and data extraction based on systematic methodology.

• Guide and perform benefit-risk assessments, adverse event profiling, and gap analyses; support development of clinical evidence strategies to address data gaps.

• Collaborate with cross-functional teams and leadership to align clinical data strategies with product labeling, regulatory submissions, design changes, and EU MDR certification.

• Manage design and quality activities that impact clinical documentation, assess implications for ongoing strategies, and coordinate resource needs with leadership.

• Support the development of regulatory responses and evidence strategies for technical documentation submissions across global markets.

Qualifications:

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

• Minimum of 6 years' professional experience in a scientific, engineering, clinical, or medical device environment.

• Minimum of 3 years' experience in at least one of the following areas:
 • Development of CERs and PMCF documents in compliance with EU MDR 2017/745 and applicable guidance
 • Clinical treatment/management of EP patients (e.g., radiofrequency, cryoablation, pulsed field ablation)
 • Preparation and submission of EU MDR Technical Documentation for market access

• Demonstrated leadership experience, including mentoring or managing junior staff or external contractors.

• Strong understanding of clinical evidence types (literature, clinical trials, real-world data), including their benefits and limitations.

• Experience applying regulatory and clinical knowledge to shape clinical data strategies.

• Strong analytical and scientific writing skills, with experience evaluating and interpreting medical literature.

• Proficiency in English at a C1 level (or equivalent 85–90% proficiency).

Preferred qualifications:
• 3+ years of professional experience across multiple of the required expertise areas listed above.

• Knowledge of electrophysiology devices and related medical terminology.

• Experience working within the medical device industry with understanding of global regulatory frameworks (EU MDR, FDA).

• Familiarity with Quality Management Systems and Risk Management documentation (e.g., Hazard Analysis, Risk Reports, Risk Plans).

• Experience with technical and engineering documentation, including protocol/report generation and interpretation of international standards.

Requisition ID: 614675

Minimum Salary: $82600 

Maximum Salary: $156900 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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 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 status, age, mental or physical disability, genetic information or any other protected class.

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.