Product Risk Specialist III

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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.

Posting timeline:

This position will be posted from 12/4/25-12/7/25

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

Minimum Salary:$79700

Maximum Salary: $151400

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see — 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…