The Global Recall Manager is responsible for ensuring that all divisional recalls and customer notifications are processed accurately, and that any required global escalations are performed in a timely manner in line with regulatory expectations. In addition, this position is responsible for assisting in preparation, implementation, conformance and verification of Company quality policies and regulatory affairs procedures in compliance with 21 CFR Part 820 Quality System Regulations, ISO 13485 standards, all domestic and foreign import/export regulations, Thermo Fisher Scientific RA Compliance programs, and applicable International standards.
The Global Recall Manager chairs the Microbiology Field Action Review Board and is the primary divisional representative on the divisional recalls review panel, and PQAC. This position is responsible for ensuring all recalls throughout MBD are filed with Corporate (SDG) and that they provide monthly updates until the recall is closed with the appropriate regulatory agency
- Lead the global corrections and removal process to ensure regulatory deadlines are met, recalls are effective and that they are closed in a timely manner.
- Establish a consistent global process to manage incoming complaints from all sources, through risk assessment, and into site level investigation.
- Chair the Field Action Review Board (FARB) to ensure that recall decision are timely, appropriate and consistent. This position will setup and chair the meetings. He/she will work with each site to insure the completeness of their investigations and present that data to the FARB. He/She will recommend a decision to recall or take other action and will ensure the decisions are consistent from site to site.
- Liaise with clinical representatives to ensure health assessments are completed to support recall decisions.
- Track post-market metrics to ensure that the divisional leadership team is aware of situations that may lead to customer dissatisfaction.
- Monitor and review process to track ongoing complaint investigations to root cause and any subsequent CAPA or project deployed to remediate.
- Liaise with Corporate QARA and Legal to ensure that they are informed about complaints and recall trends and the status of remediation programs.
- Prepare and submit all required Submissions to Foreign Governments.
- Review promotional information and product literature to ensure regulatory compliance.
- Review/approve documents including Device Requests, Label Copy, Device Master Records, Document Control Changes, and Standard Operating Procedures.
- Review governmental rulings to determine change and probable effects on facility activities.
- Participate as a team member in Vendor, Customer, and Corporate audits.
- Bachelors of Science/Arts Degree
- 5 years of experience in Medical Device Quality or Regulatory Affairs
- 3 years of experience Global Post-Market Surveillance (including FDA, MHRA and other international regulatory bodies).
- Experience of risk management
- Degree in microbiology or bacteriology
- Experience with PPI, DMAIC, Six Sigma and/or Lean
- A track record of successfully leading through uncertainty and influencing without direct authority
- Excellent oral and written communication skills
- Must be able to work independently, by taking general concepts and direction to produce desirable compliant outcomes
- Ability to prioritize multiple tasks and to function effectively in a global, multi-site organization
- Demonstrated ability to inspire and lead cross-functional teams
- Experience of working with clinical decision making tools