Location: Marlborough,MA, USA
Additional Locations: US-MA-Marlborough; US-MN-Maple Grove
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:
* 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
Required Qualifications:
* Bachelor's degree in business administration, life sciences, medical sciences (e.g. nursing, pharmacy, etc.), industrial engineering or field related
* 2+ years' experience in clinical, regulatory, quality, or medical safety in a medical device company (Or an equivalent combination of education and experience)
Preferred Qualifications:
* Prior experience with clinical evaluation reports (CER), medical writing, technical writing, and/or regulatory writing
* Experience with medical literature reviews, CER writing, and/or a medical background is strongly preferred
* Experience or education in neuroscience, neurovascular interventions, or neurosurgery is strongly preferred
* Microsoft Office Word, Excel, Powerpoint; previous experience or willingness to learn to use reference documentation software (Distiller, Endnote, ReadCube, etc)
Requisition ID: 595117
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
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