Senior Clinical Evaluation Scientist

Additional Location(s):  N/A

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:

As a Senior Clinical Evaluation Scientist supporting the Electrophysiology (EP) Solutions portfolio, you’ll play a critical role in shaping global evidence-based clinical strategies. Your role will develop key clinical documentation that synthesizes complex data across sources to support product approval, market access, and compliance with post-market requirements. This is a highly collaborative role and will allow you to work across functions to develop Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) reports, and Summary of Safety and Clinical Performance (SSCP) reports, ensuring alignment with global clinical and regulatory standards. Strong analytical and writing skills, combined with scientific and regulatory insight, are essential for success in this position.

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 Minnesota or Marlborough 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. 

Your responsibilities will include:

• Compile, appraise, and evaluate data from diverse sources including clinical trials, medical literature, design verification/validation data, and product complaint data.
• Align data with risk documentation and product labeling to identify clinical gaps or emerging concerns.
• Collaborate with librarians to design literature search strategies and perform systematic reviews including screening, appraisal, and data extraction.
• Partner with medical experts to define clinical benefit statements and align pre- and post-market evidence strategies accordingly.
• Conduct analyses to evaluate product benefit/risk profiles, safety signals (e.g., adverse event trends), and performance indicators.
•  Identify evidence gaps and contribute to strategies for generating new data.
• Develop global clinical data strategies in collaboration with leadership to support market access for new product development, sustaining products, and design changes.
• Support Design and Quality activities, including impact assessments and new clinical data planning, ensuring cross-functional alignment and resourcing.
• Contribute to development and execution of regulatory submission strategies.

Required qualifications:

• Minimum Bachelor’s, Master’s, or advanced degree (PhD, research-based MS, MD, RN, DVM) in a scientific, medical, or engineering field.
• Minimum of 4 years' experience in a scientific, engineering, medical, or medical device environment.
• Minimum of 3 years' 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

• Strong understanding of different types of clinical evidence (e.g., literature, clinical trials, real-world evidence) and their strengths and limitations.
• Proven ability to strategically apply regulatory and medical knowledge to clinical data planning.
• Proficient in literature analysis and appraisal.
• Demonstrated medical and scientific writing skills.

Preferred qualifications:

• Minimum of 3 years' experience in more than one of the areas listed above.
• Familiarity with Quality Management System documentation, including Risk Management Documents (e.g., Hazard Analysis, Risk Management Report, Risk Management Plan).
• Experience working with engineering documentation such as test protocols, test reports, and relevant international standards.

Requisition ID: 622739

Minimum Salary: $85000 

Maximum Salary: $161500 

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 identity, 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.