Senior Product Risk Specialist at Boston Scientific Corporation Malaysia

Georgetown, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Jan, 26

Salary

164500.0

Posted On

09 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Evaluation Reports, Risk Assessment, Regulatory Compliance, Medical Writing, Cross-Functional Collaboration, Data Interpretation, Documentation Quality, Clinical Trials, Mentoring, Project Management, Safety Signals, Quality Systems, Attention to Detail, Organizational Skills, Technical Writing, Device Classifications

Industry

Medical Equipment Manufacturing

Description

Additional Location(s): US-MN-Maple Grove; US-MA-Marlborough 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: In this role, you will play a pivotal part in ensuring the safety and clinical compliance of Boston Scientific's global product portfolio. You will be responsible for the analysis, documentation, and communication of clinical product risk across the project and product lifecycle. This includes detecting safety signals, assessing risk, and guiding teams in maintaining alignment with regulatory and corporate standards. Your work will directly support our mission to transform lives through innovative medical solutions that improve the health of patients around the world. 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: Produce and maintain Clinical Evaluation Reports (CERs) for the global product portfolio in accordance with company SOPs and applicable regional regulations (e.g., FDA 510(k)/PMA, EU MDR, Health Canada, PMDA, etc.) Collaborate with cross-functional partners to support clinical risk analysis and enhance documentation quality Conduct and analyze literature searches to interpret and summarize harms, hazards, alternative therapies, and device-specific benefits for risk assessment Identify the need for and generate clinical risk-related documents for commercial or in-development products to meet both internal and external regulatory requirements Act as a liaison between the Clinical Product Risk function and cross-functional project teams, ensuring effective communication of relevant information Collaborate with Clinical and R&D functions to develop consistent clinical deliverable criteria and rationalize the need (or absence) of clinical trials Serve as a mentor and subject matter expert in clinical product risk activities; provide consulting support on complex projects and product grouping strategies Represent the function as a product SME during audits (FDA, Notified Body, and internal), including preparation of documentation and CAPA responses Qualifications: Required qualifications: A bachelor's degree and minimum of 3 years' experience in life sciences, engineering, or a related field Or minimum of 7 years' experience in the respective field without a degree Medical and/or technical writing experience Preferred qualifications: Experience in the medical device industry Knowledge of therapeutic areas and device classifications Strong ability to collaborate cross-functionally and at all organizational levels Proven skills in interpreting and synthesizing clinical and commercial data Excellent attention to detail and strong organizational skills Solid understanding of business procedures, quality systems, and regulatory compliance Requisition ID: 615737 Minimum Salary: $ 86600 Maximum Salary: $ 164500 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. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Responsibilities

You will ensure the safety and clinical compliance of Boston Scientific's global product portfolio by analyzing and documenting clinical product risk. This includes detecting safety signals, assessing risk, and guiding teams to maintain regulatory alignment.