Boston Scientific Senior Product Risk Specialist 

United States, Minnesota 

997763569

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

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

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.