Boston Scientific Principal Product Risk Specialist 

United States, Minnesota 

50939583

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 obtain additional input to aid in clinical risk analysis
• Analyze literature searches on products/product families to interpret and summarize harms, hazards, alternate therapies and device specific benefits from literature to support risk assessment.
• Identifies the need for and/or generates clinical risk related documents on BSC products (commercial or under development) to support internal BSC and external regulatory agency requirements
• Serves as a liaison between Clinical Product Risk function and project team. Clearly communicates pertinent project/function information.
• Collaborate with Clinical and R&D to develop common Clinical deliverable criteria and strategize justification for no clinical trial or aid in development of clinical trial rationalization plan.
• Mentors and serves as subject matter expert in key clinical product risk activities; participates as a risk management consultant for complex projects and for grouping similar products into logical and sustainable structure.
• Serve as product SME during FDA, Notified Body, and internal audits; prepare back‑room documentation and CAPA responses.

Required Qualifications:

• A bachelor’s degree and 5+ years of professional experience in life sciences, engineering, or related field.
• Or 10+ years of professional experience in the respective field.
• Medical and/or technical writing experience required

Preferred Qualifications:

• Medical Device industry experience preferred
• Therapeutic area knowledge desired
• Ability to work cross-functionally at all levels of organization
• Proven ability to analyze, interpret and synthesize clinical and commercial data
• Attention to detail and strong organizational skills.
• Understanding and application of business concepts, procedures and practices. Will perform this job in a quality system environment and failure to adequately perform tasks can result in noncompliance with governmental regulations.
  

Maximum Salary: $ 188300

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.