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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Senior Manager- Field Correctives Actions


Reference:JCAO3009 Location: Republic of Ireland
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Customer Complaints, Quality Manager

Our client a Global Healthcare company currently seeks a Senior Manager Field Corrective Actions to join their team. Reporting to Senior Director the position will be responsible for overseeing Risk /Health Hazard Evaluation processes, Product Safety Review (Recall) Boards, and Field Corrective Actions execution. This Field Correctives Actions Manager will also supervise a team, maintain close working relationships with cross-functional stakeholders and interact with Executive Management on relevant issues.

Role/Responsibilities:

  • Run Product Safety Review Board meetings for Field Safety Corrective Action (FSCA) decisions.
  • Advise Quality and Business leaders on potential global recall regulations (e.g. 21CFR806, MDRArticle89) and strategies for complex issues. o Ensure FSCA strategy is understood, documented, and communicated. As needed, work with Business Unit and CMA partners to develop strategies for Field Safety Notices and manage actions to the strategy.
  • Ensure robust and timely completion of Health Hazard Evaluation packs for Product Safety Review Board (i.e. decision). Monitor process and establish metrics.
  • Manage global Field Corrective Actions and maintain close working relationships with Regulators and Notified Bodies.
  • Manage the process for all enterprise FCA’s. Ensure customers letters are authored and approved, regulatory queries are managed, effectiveness is monitored, and the FCA is closed with applicable agencies.
  • Advise teams on appropriate responses to FCA queries, assimilate cross-functional responses, including CAPA verbiage, and act as final approval on the response before submission to authorities. Seek legal feedback and work with TFX legal team where needed.
  • Lead interactions regarding FSCAs with Competent Authorities, Regulators, and Notified Body, including but not limited to emails, conference calls, audits, and face to face meetings. When needed, speak on behalf of the Review Board to explain the decision and rationale for a safety notice or no action decision.
  • Own the global Health Hazard and Risk Evaluation processes. o Serve as SME on Health Hazard Evaluation processes and escalations, including serving as the primary independent reviewer for EIF Technical Reviews; provide considers, challenge owners, ensure proper scoping, occurrence, and severity calculations.
  • Support the expansion and enhancement of post-market surveillance activities. Collect data metrics and escalate to QDAR forums, including but not limited to Executive Management Review. Drive continuous improvement of the HHE & FCA processes.
  • Managerial responsibility for Global Field Corrective Action personnel. Development of direct report KPIs and goals and objectives and the regular review of same.
  • Maintain close working relationships with Product Quality Assurance, Clinical Medical Affairs, Legal Counsel, and Complaint Handling /Vigilance groups in US and EMEA.
Skills/Experience:
  • Bachelor of Sciences degree in a technical, engineering, medical or science discipline.
  • Minimum 10 years experience in the medical device industry in quality assurance/quality engineering functions commensurate with the responsibilities outlined above.
  • Minimum 5 years managing quality assurance/quality engineering resources.
  • Extensive knowledge and understanding of Quality and Regulatory requirements and regulations, including but not limited to FDA's 21 CFR Part 820 & 806 (Quality System Regulation), ISO 13485 Quality System requirements, Council Directive 93/42/EEC {Medical Device Directive), MEDDEV, Canadian Medical Device Regulations, Japanese JPAL requirements.
  • Proven leadership in Field Corrective Actions including experience with regulatory inspections/audits, specifically FDA and Competent Authority inspectors.
  • Good Business Acumen with the ability to prioritize tasks and manage several critical projects and tasks simultaneously. The ability to interface with all levels of management.
  • Experience performing internal and external audits
  • Excellent attention to detail and the ability to communicate clearly and accurately, verbally and in writing.
  • Knowledge and experience with corrective and preventive actions systems.
  • Knowledge and experience in process monitoring methods and techniques.
  • Experience with QMS Applications, specifically Agile and SAP, preferred.

For further information please contact James Cassidy [email protected] or call in confidence 086 0204322