Safety Operations Sr. Specialist – ALCON

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  • Perform Adverse Event training for employees, vendor and customers and maintain training records
  • Review, revise and provide feedback on the vigilance language within the contracts to ensure the vendors and customers are compliant to vigilance requirements
  • Track, coordinate, and implement any change in global regulations for medical devices to ensure compliance to applicable Health Authority (HA) requirements
  • Partner with functional and global teams as needed to perform the job responsibilities and escalate any issues or challenges in a timely manner
  • Serve as a subject matter expert during internal and external audits
  • Coordinate and communicate as needed with HA authorities to understand and implement change in regulations within Alcon quality system
  • Own the processes, drive continuous improvements to gain efficiency and effectiveness as required
  • Responsible to investigate root-cause, implement immediate mitigation and drive corrective actions for any audit findings or deviations as applicable
  • Good understanding of medical device reporting requirements and regulations
  • Experience with vigilance clause and contracts review process
  • Working knowledge of electronic databases and knowledge of IT systems
  • Experience with conducting training and performing communication with external stake holders and customers
  • Awareness of international regulatory agency guidelines and requirements for vigilance reporting
  • Ability to understand customer requirement. Ability to communicate clearly both verbally and in writing.
  • Being proactive, process ownership and responsibility, active involvement

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