Product Risk Specialist II

bostonscientific•Maple Grove, MA

11d•$72,800 - $138,300•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.