Senior Project Manager, Clinical Risk Evaluation

Provide technical and strategic expertise throughout the product development and lifecycle process Manage and align risk information for Neuromodulation products Create and maintain Risk Evaluation Files and associated documentation Identify, interpret, evaluate, and incorporate literature, clinical data, and medical references Oversee CROs and manage timelines, project delays, and risks Lead risk alignment committee meetings and facilitate multidisciplinary team participation Communicate risk information across clinical safety, clinical science, operations, product performance, medical affairs, R&D, quality engineering, regulatory affairs, labeling, senior management, and external vendors Develop Risk Evaluation File procedures, templates, SOPs, and DOPs in accordance with applicable regulations Guide and oversee medical writers developing Clinical Evaluation Reports, SSCPs, and related documents Set deliverables and project timelines and ensure deadlines are met Facilitate document exchange between internal stakeholders and external vendors Review, edit, and write portions of Clinical Evaluation Reports and associated documents Participate in or lead regulatory responses to Notified Body questions Provide strategic guidance on regulatory requirements for clinical data and clinical evaluations Support internal and external audits, root cause analysis, corrective and preventive actions, effectiveness monitoring, and quality metrics Develop and roll out functional training and innovative solutions for the Clinical Risk Evaluation group Review IFUs, patient guides, risk management documents, clinical evaluation protocols and reports, investigator brochures, study protocols, informed consent forms, and physician training materials Respond to complex customer queries related to risk information Review and provide input on PMS and PMCF plans Facilitate regulatory submissions and communications with Regulatory Affairs Perform proactive clinical trial signal detection Participate in clinical corrective action board meetings Mentor less-experienced staff Requirements Bachelor’s Degree in related field OR an equivalent combination of education or work experience Minimum 6 years related work experience Strong understanding of the specified functional area Experience in MEDDEV 2.7/1 Rev. 4 and MDR Article 61 Solid understanding and application of business concepts, procedures and practices Ability to work in a quality system environment and comply with governmental regulations Ability to analyze data and evaluate identifiable factors Judgment in selecting methods and techniques for obtaining solutions Sound knowledge of alternatives and their impact on the business unit Preferred: Master’s degree Preferred: Experience in medical device clinical research, medical writing, or a combination Strong project management skills Experience in Active and/or Implantable Medical Devices or PSUR writing desired Track record in clinical, medical, or scientific publication is a plus Core Competencies Demonstrates expertise in risk management and regulatory compliance for Neuromodulation products, with a strong focus on clinical evaluation, project management, and cross-functional communication. Proficient in developing and maintaining Risk Evaluation Files and associated documentation in accordance with applicable regulations. Highest-signal resume keywords Risk Management Regulatory Compliance Clinical Evaluation Reports Project Management Medical Device Experience Hard Skills Risk Evaluation Files Clinical Data Analysis MEDDEV 2.7/1 Rev. 4 MDR Article 61 Quality System Compliance Clinical Trial Signal Detection PSUR Writing SOP Development Data Evaluation Regulatory Submissions Soft Skills Judgment Communication Mentoring Collaboration Problem Solving Industry Keywords Neuromodulation Medical Devices Clinical Research Medical Writing Quality Metrics #J-18808-Ljbffr Jobtailor