Principal Clinical Scientist II, Neuromodulation
- Employer
- Boston Scientific
- Location
- Valencia, CA
- Closing date
- Sep 20, 2021
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Uses comprehensive skill set and understanding of clinical evaluation and risk for medical devices as they relate to multiple therapeutic areas. Collaborates with various internal functions to provide clinical support and expertise for projects. Represents function to internal cross-functional partners.
This role can sit remotely.
Your responsibilities include:
Support product development and sustaining teams in the evaluation of product risk and design control process. Ensure clinical accuracy in risk documentation, e.g. hazard analysis (HAs), risk management plans/reports (RMP/RMR), and product labeling, i.e. Instructions for Use (IFU). Utilize understanding of therapeutic area and procedures to identify and interpret information impacting quality.
Author clinical evaluation documents, e.g. clinical evaluation plans and reports (CEP/CER), post market clinical follow-up (PMCF) plans, summary of safety and clinical performance (SSCP) for support of safety and performance for product approval and identification of harms.
Ensure linkage between clinical harms identified in clinical evaluations and risk analysis throughout the product lifecycle; create/maintain risks lists for clinical studies and IFUs.
Serve as Clinical representative on project teams; Build and maintain strong relationships with internal scientific, technical, and organizational leaders to support Regulatory, Clinical, and product strategies; clearly communicate pertinent project/function information.
Contribute to process improvements within function.
Serves as function support in Regulator responses, and in internal and external audits including audit participation, preparing audit responses and supporting process improvements resulting from the audit.
Assist Medical Director, Medical Safety, and Clinical study teams with product risk research and information as needed.
What we're looking for:
Basic Qualifications
9+ years of relevant industry experience
Bachelor's Degree in relevant field
5+ years experience writing clinical evaluation documents
Experience with CEP/CER, PMCF, and SSCP documents and plans
Preferred Qualifications
Master's Degree in relevant field
This role can sit remotely.
Your responsibilities include:
Support product development and sustaining teams in the evaluation of product risk and design control process. Ensure clinical accuracy in risk documentation, e.g. hazard analysis (HAs), risk management plans/reports (RMP/RMR), and product labeling, i.e. Instructions for Use (IFU). Utilize understanding of therapeutic area and procedures to identify and interpret information impacting quality.
Author clinical evaluation documents, e.g. clinical evaluation plans and reports (CEP/CER), post market clinical follow-up (PMCF) plans, summary of safety and clinical performance (SSCP) for support of safety and performance for product approval and identification of harms.
Ensure linkage between clinical harms identified in clinical evaluations and risk analysis throughout the product lifecycle; create/maintain risks lists for clinical studies and IFUs.
Serve as Clinical representative on project teams; Build and maintain strong relationships with internal scientific, technical, and organizational leaders to support Regulatory, Clinical, and product strategies; clearly communicate pertinent project/function information.
Contribute to process improvements within function.
Serves as function support in Regulator responses, and in internal and external audits including audit participation, preparing audit responses and supporting process improvements resulting from the audit.
Assist Medical Director, Medical Safety, and Clinical study teams with product risk research and information as needed.
What we're looking for:
Basic Qualifications
9+ years of relevant industry experience
Bachelor's Degree in relevant field
5+ years experience writing clinical evaluation documents
Experience with CEP/CER, PMCF, and SSCP documents and plans
Preferred Qualifications
Master's Degree in relevant field
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