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 tina.egan@collinsmcnicholas.ie 09064 78104.

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

Setting the Standards for Excellence in Recruitment

To see a full list of jobs available across Ireland please visit our website at www.collinsmcnicholas.ie

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