Principal Product Risk Specialist

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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:
Responsible for the analysis and communication of clinical product risk across the project and product lifecycle. Provides guidance in safety signal detection and assessment to communicate safety risks to project teams and senior management. Ensures compliance with regulatory standards and guidelines, and corporate standard operating procedures as they relate to safety risk management.

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, EUMDR, Health Canada, PMDA, etc.). Collaborate with cross-functional partners to obtain additional inputto 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.

Visa Sponsorship:
Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

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

• 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.

Requisition :611112

Minimum Salary: $
103700

Maximum Salary: $
197000

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…