Hybrid Executive Director, CSRM Device and Product Quality

Posted 15 minutes ago

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About the role

  • 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

Job type

Experience level

Lead

Salary

$310,900 - $489,400 per year

Degree requirement

Postgraduate Degree

Location requirements

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