Clinical Product Surveillance Specialist

Medline Industries LP

Base: $79,000.00 - $119,000.00 annual; bonus/equit...
Not specified
Post-market complaint investigation
Adverse event reporting (mdrs/icsrs)
Fda regulatory compliance knowledge
Medline Industries LP is seeking a Clinical Product Surveillance Specialist to manage post-market complaints and provide clinical resource support, ensuring patient safety and compliance within a cross-functional team. The ideal candidate will hold a Bachelor's Degree in Nursing with relevant clinical experience and an active RN license, focusing on risk management and safety evaluation in a medical device context

Job Summary

  • The role acts as a patient safety advocate investigating domestic and international post-market complaints with potential safety issues.
  • Employees must ensure adverse event reports are processed and submitted to the FDA within strict regulation timelines.
  • Medline offers a competitive total rewards package including health insurance, 401(k) contributions, and paid time off.

Matching Summary

Match Score: 85

Medline Industries LP is seeking a Clinical Product Surveillance Specialist to manage post-market complaints and provide clinical resource support, ensuring patient safety and compliance within a cross-functional team. The ideal candidate will hold a Bachelor's Degree in Nursing with relevant clinical experience and an active RN license, focusing on risk management and safety evaluation in a medical device context.

Salary

Base: $79,000.00 - $119,000.00 Annual; Bonus/Equity: Bonus and/or incentive eligible; Benefits: Health insurance, life/disability, 401(k), PTO

Skills & Requirements

Must-have

  • Post-market complaint investigation
  • Adverse event reporting (MDRs/ICSRs)
  • FDA regulatory compliance knowledge
  • Risk management and CAPA processes
  • Cross-functional collaboration skills

Nice-to-have

  • Proactive problem-solving mindset
  • Strong analytical data presentation
  • Customer-focused results orientation
  • Effective time management skills

Key Requirements

  • Bachelor's Degree in Nursing (BSN)
  • Active Registered Nurse (RN) licensure
  • 5 years patient care experience OR 2 years similar role
  • Experience in Perioperative, Critical Care, or Wound Care settings
  • Knowledge of 21 CFR and ISO 13485 regulations

Work Rights

Not specified

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