Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
About the role:
The Sr Product Risk Specialist is 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:
Identify appropriate scope and comparative information for CES/CRBA and drive generation or updates for those documents. Collaborate with cross-functional partners to obtain additional input (i.e. Quality for Field Experience data) to aid in clinical risk analysis
Conduct literature search on products/product families to interpret and summarize harms, hazards, alternate therapies and device specific benefits from literature; collect and summarize primary data from the Design History File 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. Collaborate with Medical Sciences by providing harms, hazard and benefits information for the development/updates of the DFU, RAWB and FMEA documents.
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
What we’re looking for in you:
Bachelor’s degree in Science/Engineering required, preference to RN/DVM; Master’s or above preferred.
3 + years related experience, medical device experience preferred, clinical and risk management experience.
Analytical skills - ability to synthesize and summarize medical and technical literature. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
Medical scientific writing skills
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.
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Executive / senior industry position
Maple Grove , United States