Product Risk Specialist II at Boston Scientific Corporation Malaysia

Georgetown, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Mar, 26

Salary

138300.0

Posted On

16 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Risk Analysis, Regulatory Compliance, Cross-Functional Collaboration, Medical Literature Reviews, Data Summarization, Risk Management, Clinical Evaluation Reports, Project Communication, Mentorship, Audit Participation, Microsoft Word, Microsoft Excel, Microsoft Teams, Reference Management Software, Influencing Skills, Collaboration Skills

Industry

Medical Equipment Manufacturing

Description

Additional Location(s): US-MA-Marlborough; 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: Responsible for the analysis and communication of clinical product risk across the project and product lifecycle. This role provides guidance in safety signal detection and assessment, ensuring timely communication of safety risks to project teams and senior leadership. The position ensures compliance with regulatory standards, global guidance, and corporate SOPs related to safety risk management. 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: Identify appropriate scope and comparative data for CER, CEP, PMCF Plans and Reports, and lead their development or updates. Collaborate cross-functionally to obtain input (e.g., Quality for Field Experience data) to support robust clinical risk analysis. Conduct literature searches on products and product families to summarize harms, hazards, alternate therapies, and device-specific benefits. Collect and summarize primary data from the Design History File to support clinical risk assessments. Identify the need for and/or generate risk management documents for BSC products (commercial or in development) to support internal and external regulatory requirements. Act as a liaison between the Risk Management function and project teams, clearly communicating project and function-related updates. Collaborate with Clinical and R&D teams to develop clinical deliverables and justify when clinical trials are not required or provide input for trial rationalization. Support Medical Sciences by providing harms, hazards, and benefits data to inform updates to DFU, RAWB, and FMEA documentation. Serve as a subject matter expert and mentor in key risk management activities; consult on complex projects and sustainable product grouping strategies. Depending on level, serve as SME and function representative during internal and external audits—participating in audit prep, back room SME support, response drafting, and follow-up actions. Qualifications: Required qualifications: Bachelor's degree or higher in Business Administration, Life Sciences, Medical Sciences (e.g., Nursing, Pharmacy), Industrial Engineering, or a related field. 2+ years' experience in the medical device, healthcare, or a related industry. Or an equivalent combination of education and experience. Preferred qualifications: Advanced degree preferred. Experience with medical literature reviews, clinical evaluation reports, or other regulatory documentation. Familiarity with Microsoft Word, Excel, Microsoft Teams, and reference management software. Proven ability to influence without authority. Strong collaboration skills with internal stakeholders. Requisition ID: 620628 Minimum Salary: $ 72800 Maximum Salary: $ 138300 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

The Product Risk Specialist II is responsible for analyzing and communicating clinical product risk throughout the project and product lifecycle. This includes guiding safety signal detection and ensuring compliance with regulatory standards.