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 applicabl