Boston Scientific Sr Product Risk Specialist - Endoscopy 

United States, Massachusetts, Marlborough 

683203117

US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove

Your responsibilities will include:

• Identify appropriate scope and comparative information for Clinical Evaluation Reports and drive generation or updates for those documents. Collaborate with cross-functional partners to obtain additional input to aid in clinical risk analysis
• Conduct 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 risk management related documents on BSC products (commercial or under development) to support internal BSC and external regulatory agency requirements
• Serves as a liaison between Risk Management 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 risk management activities; participates as a risk management consultant for complex projects and for grouping similar products into logical and sustainable structure.
• Dependent on level, may serve as SME and Function representative in internal and external audits including audit participation, back room SME, preparing audit responses and supporting process improvements resulting from the audit.

Required qualifications:

• Minimum of a bachelor’s degree in Life Sciences
• Minimum of 5 years' experience in Clinical or Research environment
• Medical and/or technical writing experience

Preferred qualifications:

• Medical Device industry experience preferred
• Therapeutic area knowledge desired
• Prior experience of analysis and communication of clinical product risk as it relates to products
• Prior experience preferred of the clinical evaluation strategy for including development of CER, PMCF, and SSCP reports

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.