Collins McNicholas

The successful PMS and Corrective Action Manager will be  responsible for monitoring, understanding and managing product quality customer complaints received by the company.  He/She will also manage Global Field Actions and will oversee a team to manage activities ensuring Senior management are informed as required on relevant issues.

Key Responsibilities

  • Management of company complaint handling, vigilance reporting and field safety corrective action systems and ensuring same is compliant with current regulations.
  • Development and provision of a harmonized complaint reporting and management system in International including:
    • Streamline complaint handling & vigilance processes across International.
    • Support implementation of an integrated complaint management IT system across International.
    • Development of complaint & vigilance metrics to International Senior Management.
    • Root cause analysis improvement and standardization of complaint investigation reports across manufacturing sites.
    • Coordinate complaint follow-up and completion of appropriate corrective actions.
    • Manage the coordination of Global Field Safety Corrective Actions.
    • Support for the risk management process, provision of complaint data to risk management process to allow the files to be maintained as current.
    • Maintain close working relationships with Regulators and Notified Bodies Globally.
    • Managerial responsibility for Post Market Surveillance personnel. Development of direct report KPIs and goals and objectives and the regular review of same.
    • Support the expansion and enhancement of post-market surveillance activities as it develops.
    • Maintain close working relationships with complaint handling and vigilance group in US headquarters.

Essential Skills / Experience

  • Engineering/Science qualification with 5 years of working within complaints in a medical device environment.
  • Proven experience as an effective Post Market Surveillance & Field Corrective Action Senior Manager in the Medical Device Industry.
  • Excellent technical writing experience within a medical device environment – essential.
  • Knowledge of Quality and Regulatory requirements and regulations.
  • Attention to detail and accuracy – essential
  • Ability to work well under deadlines and pressure
  • Problem solving skills for developing creative solutions and meeting objectives are required.

Full spec on request

For more information or to apply please contact Tina Egan on 09064 78104.

Please Note: Collins McNicholas will not forward your details to any company without your prior approval.

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