Senior Product Risk Specialist

Boston Scientific-posted 2 months ago
$86,600 - $164,500/Yr
Full-time • Mid Level
Hybrid • Maple Grove, MN
5,001-10,000 employees
Merchant Wholesalers, Durable Goods
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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.

  • 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
  • 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
  • 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
  • 401k
  • health_insurance
  • dental_insurance
  • vision_insurance
  • life_insurance
  • disability_insurance
  • paid_holidays
  • tuition_reimbursement
  • professional_development
  • employee_stock_purchase_plan
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