Senior Project Manager, Clinical Risk Evaluation | Abbott (On-site)
Job Summary
Abbott, a global healthcare leader, is hiring a Senior Project Manager, Clinical Risk Evaluation to join its medical device division in multiple locations: Plano TX, Austin TX, Maple Grove MN, and Santa Clara CA. This on-site role focuses on managing and aligning clinical risk data for Neuromodulation products, overseeing Risk Evaluation Files (REFs), coordinating cross-functional teams, and driving regulatory-compliant risk strategies throughout the product lifecycle.
Key Responsibilities
Independently create and maintain Risk Evaluation Files (REFs) for Abbott products.
Oversee CROs, manage timelines, identify risks, and develop mitigation strategies.
Lead risk alignment committee meetings; ensure stakeholder collaboration and decision-making.
Develop and maintain REF procedures and templates in line with applicable regulations.
Manage Clinical Evaluation Reports (CERs), SSCPs, and associated deliverables; guide medical writers.
Facilitate document exchange across teams (Regulatory, Clinical, Quality, R&D, Marketing).
Review and edit CER documents; contribute to regulatory responses and Notified Body submissions.
Provide strategic regulatory guidance to new and sustaining product teams.
Support audits, root cause analysis, CAPA processes, and quality improvement initiatives.
Mentor junior staff and promote knowledge sharing within Clinical Risk Evaluation group.
Review risk-related sections in IFUs, clinical protocols, CERs, labeling, and PMS plans.
Participate in proactive clinical signal detection and corrective action meetings.
Required Skills & Qualifications
Bachelor's degree in a relevant field or equivalent work experience.
Minimum 6 years of related work experience in clinical risk, regulatory affairs, or medical devices.
Strong understanding of business processes, clinical evaluation, and risk management.
Ability to solve complex problems using judgment within established practices.
Excellent project management and cross-functional collaboration skills.
Preferred Skills & Qualifications
Bachelor’s in biomedical/medical field; Master’s preferred.
Experience in medical device clinical research or medical writing.
Background in Active/Implantable Medical Devices or PSUR preparation.
Publication or scientific writing experience is an advantage.
Perks & Benefits
Competitive Salary Range: $75,300 – $150,700 annually.
Free medical coverage through HIP PPO plan.
High employer contribution to 401(k) savings plan.
Tuition reimbursement, Freedom 2 Save debt program, FreeU bachelor’s degree pathway.
Global career development and training opportunities.
Company Description
Abbott is a world-renowned healthcare and diagnostics innovator dedicated to improving lives through cutting-edge medical device technologies. Serving over 160 countries, Abbott’s portfolio spans diagnostics, devices, nutrition, and branded pharmaceuticals, helping millions lead healthier lives.
Work Mode
On-site – Locations: Plano TX, Austin TX, Maple Grove MN, Santa Clara CA, United States.
Call to Action
Ready to lead clinical risk strategy for life-changing medical technologies? Apply now and join Abbott’s pioneering team in advancing patient health and safety worldwide.
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