Executive Director providing strategic leadership in device safety and product quality for a global health care leader. Ensures compliance, patient safety, and effective collaboration across various departments.
Responsibilities
Provides strategic and operational leadership for a global Center of Excellence delivering medical and scientific expertise in device safety, health hazard oversight, and product quality medical risk assessment
Sets clinical risk management strategy, governance, and compliant processes for medical support of devices and combination products across the full product lifecycle
Leads strategic oversight of device risk management activities
Partners with CSRM Therapeutic Area leaders
Defines strategy and standards for medical assessment of product quality observations and deviations
Represents CSRM leadership on shared governance committees with Manufacturing and other enterprise stakeholders.
Requirements
M.D. with 7–12 years of relevant experience in clinical safety, pharmacovigilance, or related safety disciplines, including 3–5 years of experience supporting manufacturing safety and/or drug device development
Demonstrated scientific expertise, strong medical judgment, and the ability to communicate risk and benefit effectively
Thorough familiarity with global regulatory agencies and regulatory expectations
Proven leadership capability, including building and leading high–performing, cross–disciplinary teams with integrity and accountability
Outstanding interpersonal, communication, and negotiation skills.
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days
Job title
Executive Director, CSRM Device and Product Quality
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