Clinical Evaluation Scientist III at Boston Scientific Corporation Malaysia

Georgetown, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Feb, 26

Salary

144400.0

Posted On

22 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Evaluation, Medical Writing, Regulatory Standards, Data Interpretation, Benefit-Risk Analysis, Cross-Functional Collaboration, Clinical Trials, Medical Literature, Risk Documentation, Interventional Cardiology, Post-Market Requirements, Evidence Strategy, Regulatory Submissions, Analytical Skills, Safety Performance, Adverse Events

Industry

Medical Equipment Manufacturing

Description

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 this role: As a Clinical Evaluation Scientist III, you will 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. Work Mode: This role follows a hybrid work model requiring employees to be in our Maple Grove, MN office at least three days per week. Visa Sponsorship: Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your responsibilities will include: Apply analytical and methodical clinical evaluation approaches to develop benefit-risk profiles for Boston Scientific's interventional cardiology devices. Author and maintain clinical documentation including CERs, PMCF reports, and SSCPs in alignment with regulatory standards. Collaborate cross-functionally to ensure clinical content supports product approvals, indication expansions, claims, and post-market requirements. Interpret and synthesize data from multiple sources to produce high-quality, compliant clinical evaluations. Compile, appraise, and evaluate data from multiple sources including clinical trials, medical literature, design verification/validation data, and product complaint data. Includes development of literature search strategies and methodical evaluation of medical literature. Create analyses to evaluate product benefit/risk profile and safety and performance and develop profile of adverse events. Identify potential clinical evidence gaps and contribute to development of prospective evidence strategy to address gaps. Collaborate with leadership and cross-functional partners to ensure alignment of clinical data with risk documentation, and to contribute to product labeling. Aid in the development and execution of strategies for regulatory responses for regulatory submissions Required qualifications: Minimum Bachelor's degree and 3 years of medical writing experience, preferably in medical device industry Analytical skills, including strong familiarity with medical literature Proven experience writing clinical evaluation reports Proven experience applying principles of EU MDR Preferred qualifications: Preferred medical device industry experience or knowledge of interventional cardiology and related disease states Proven and demonstrated ability to understand engineering documentation, including risk documentation Proven experience with regulatory body communications Requisition ID: 618895 Minimum Salary: $76000 Maximum Salary: $144400 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.

Responsibilities

Develop clinical evaluation reports and post-market clinical follow-up reports in alignment with regulatory standards. Collaborate cross-functionally to ensure clinical content supports product approvals and post-market requirements.