Senior Project Manager, Clinical Risk Evaluation (On-Site)
Location: Plano, TX / Austin, TX
Category: Regulatory Affairs
About Abbott:
Abbott is a global healthcare leader dedicated to improving lives with cutting-edge diagnostics, medical devices, nutritionals, and branded medicines. With 114,000 employees across 160+ countries, Abbott offers an environment for career growth, innovation, and meaningful impact.
Why Join Abbott?
Career development opportunities with a globally recognized company.
Free medical coverage through the Health Investment Plan (HIP) PPO medical plan.
Competitive retirement savings plan with high employer contributions.
Tuition reimbursement and education benefits for career advancement.
A workplace recognized for diversity, inclusion, and excellence.
The Opportunity
Abbott’s Plano, TX or Austin, TX location has an opening for a Clinical Risk Evaluation (CRE) Senior Scientist/Program Manager. This role involves managing and aligning clinical risk information for Neuromodulation products throughout the product lifecycle.
Key Responsibilities:
Develop and maintain Risk Evaluation Files (REFs) for Abbott products.
Oversee clinical risk analysis, clinical evaluation plans, and regulatory documentation.
Lead cross-functional risk alignment meetings and facilitate informed decision-making.
Manage and oversee CROs, ensuring compliance with timelines and project deliverables.
Develop Standard Operating Procedures (SOPs) and process documentation for risk evaluation.
Supervise Clinical Evaluation Reports (CERs), including Summaries of Safety and Clinical Performance (SSCPs).
Provide strategic regulatory guidance for new and existing products.
Ensure compliance with internal and external audits.
Review and contribute to Post-Marketing Surveillance (PMS) Plans and Clinical Follow-Up Plans (PMCFs).
Mentor junior staff and support team development initiatives.
Qualifications:
Required:
Bachelor’s degree in a related field (or equivalent work experience).
Minimum 6 years of experience in clinical research, medical writing, or related fields.
Strong project management skills with experience handling multiple projects.
Ability to work in a regulated quality system environment.
Preferred:
Master’s degree, biomedical or medical degree.
Experience in medical devices, particularly implantable or active devices.
Expertise in PSUR writing and clinical or scientific publications.
Base Pay Range: $75,300 – $150,700 (may vary based on location).
For more details on Abbott's benefits, visit: www.abbottbenefits.com
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