Senior Clinical Evaluation Scientist

Additional Location(s):US-MN-Arden Hills; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Plymouth

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 this role:

In this role, you will collaborate within a team to develop global, evidence-based clinical strategies for cardiology medical devices, specifically in Cardiac Rhythm Management. Your responsibilities will include creating clinical documentation that systematically integrates information from various data sources. As a Senior 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 cardiology devices.

Boston Scientific will not offer sponsorship or take sponsorship of an employment visa at this time.

This is a hybrid position (in office, minimum three days per week) with the flexibility to be located in Arden Hills, MN, or Marlborough MA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

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. Compare and align this data with Risk Documentation and product labeling to identify gaps or emergent concerns.
• Develop literature search strategies in collaboration with librarians and perform methodical evaluation of medical literature including screening, appraisal and extraction of relevant data.
• Develop Clinical Benefit Statements in collaboration with medical experts and develop pre- and post-market data collection strategies to support the developed statements.
• Create analyses to evaluate product benefit/risk profile, safety (e.g., develop a profile of adverse events), and performance. Identify potential clinical evidence gaps and contribute to development of prospective evidence strategy to address gaps.
• Develop global clinical data strategies in collaboration with leadership and cross-functional partners to support market access for New Product Development, Sustaining Product compliance and Design Changes to existing products.
• Manage ongoing Design and Quality activities to support necessary changes and/or improvements to devices, including assessing the impact to existing clinical data strategies, proposing and developing new clinical data activities to meet any identified gaps, and coordinating with management to ensure resourcing needs are considered.
• Aid in the development and execution of strategies for responses for regulatory submissions.

Requiredqualifications :

• Minimum Bachelors degree in a scientific, medical, or engineering field or equivalent experience required.
• Minimum 5 years of relevant experience in a scientific, engineering, medical, or medical device space with 3 years of experience in at least one of the following:
• Writing and Developing Clinical Evaluation Plans/Reports and Post-Market Clinical Follow-Up Plans/Reports in accordance with Regulation (EU) 2017/745 of the European Parliament (i.e., EU Medical Device Regulations), relevant Medical Device Coordination Group (MDCG) guidance, and harmonized standards
• Working in the clinical treatment and management of patients receiving Cardiac Rhythm Therapies, including but not limited to- Pacemakers, Implantable Cardioverter-Defibrillators (ICDs), Cardiac Resynchronization Therapy Pacemakers/Defibrillators (CRT-P/Ds), Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs).
• Writing, Developing, Managing, and Submitting Regulatory Technical Documentation submissions in accordance with Regulation (EU) 2017/745 of the European Parliament (i.e., EU Medical Device Regulation) to support EU Market access of Cardiac Rhythm Devices
• Proven experience working with and developing regulatory strategies usingunderstanding 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.
• Proven experience in strategically applying knowledge of regulations, medical knowledge, and data types to develop clinical data strategies to support submission, while leveraging medical literature in analytical ways to enhance clinical data strategy development.

Preferred qualifications:

• Preferred Masters degree or advanced degree (PhD, research-based MS, MD, RN, DVM)
• Minimum 3 years of experience in multiple of the areas identified above
• Experience with/knowledge of 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:601608

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.