Senior Project Manager, Clinical Risk Evaluation

Jobtailor; California (MO); On-site; USD 110,000 - 170,000; Full time

Job summary

Jobtailor is seeking an experienced Regulatory Risk Lead to drive risk management for Neuromodulation products across the lifecycle.

You will oversee risk information, develop EVA files, interpret clinical data, and manage CROs and regulatory responses while mentoring staff and coordinating cross-functional teams.

Qualifications

• Bachelor’s Degree in related field or equivalent work exp.
• 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 knowledge of quality system concepts and governmental regulations.
• Ability to analyze data and evaluate identifiable factors.
• Judgment in selecting methods and techniques for solutions.
• Preferred: Master’s degree.
• Preferred: Medical device clinical research or medical writing experience.
• Strong project management skills.
• Experience in Active/Implantable Medical Devices or PSUR writing.
• Track record in clinical/medical/scientific publication is a plus.

Responsibilities

• Provide technical and strategic expertise throughout product development and lifecycle.
• Manage and align risk information for Neuromodulation products.
• Create and maintain Risk Evaluation Files and associated documentation.
• Interpret literature, clinical data, and medical references for risk assessments.
• Oversee CROs, manage timelines, delays, and risks.
• Lead risk alignment committee meetings and coordinate cross-functional participation.
• Communicate risk information across multiple stakeholders and departments.
• Develop Risk Evaluation File procedures, templates, SOPs, and DOPs per regulations.
• Guide medical writers on Clinical Evaluation Reports, SSCPs, and related documents.
• Set deliverables and timelines; ensure deadlines are met.
• Facilitate document exchange between internal stakeholders and external vendors.
• Review and draft portions of Clinical Evaluation Reports and related documents.
• Participate in regulatory responses to Notified Body questions.
• Provide regulatory guidance on clinical data and clinical evaluations.
• Support audits, root cause analysis, CAPAs, and quality metrics.
• Roll out training and innovative solutions for the Clinical Risk Evaluation group.
• Review IFUs and risk management documents and training materials.
• Respond to complex customer queries related to risk information.
• Review PMS/PMCF plans and support regulatory submissions.
• Mentor less-experienced staff.

Skills

Risk Management

Regulatory Compliance

Clinical Evaluation Reports

Project Management

Medical Device Experience

Clinical Data Analysis

Data Evaluation

Regulatory Submissions

Education

Bachelor’s Degree in related field

Master’s degree

Job description

• 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