Regulatory Post Market Surveillance Analyst
Regulatory Post Market Surveillance Analyst
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Job Description
The Regulatory Post Market Surveillance Analyst captured complaints investigates customer complaints makes initial reporting decisions files regulatory reports and ensures completeness and consistency of complaint documentation. This position reports to a local Regulatory Post Market Surveillance Supervisor or Manager with dotted line to the European Regulatory Post Market Surveillance Supervisor or Manager.
Essential Job Duties
This position has responsibility and authority for:
- Investigating complaints daily:
- European Region Complaint intake and triage for reportability
- Perform the preliminary classification of complaints and escalate complaints that require additional review.
- Perform Failure Analysis investigation review and escalate complaints that require additional review.
- File EU Manufacturer Incident Report (MIR) Reports as applicable
- Escalate Adverse Event/Serious incidents or Incident reports to Adverse Analysts as identified
- Evaluate documentation for completeness and consistency and assign additional actions as necessary to close the complaint file.
- As applicable approve final complaint file for closure after all applicable actions are completed.
- Manage complaint workload to required backlog goals.
- Review and analyze lot documentation (DHRs) to determine if there are any anomalies that maybe related to reported product failures.
- Escalate complaints to the Regulatory Post Market Surveillance Supervisor/Manager when new failure modes are encountered.
- Escalate complaints with potential related product failures to the Post Market Investigation (PMI) group
- Evaluate complaints for reporting requirements in accordance with company procedures and Regulatory requirements
- Interface with Customer Service and hospitals to gather additional information required for complaint investigation including retrieval of RMA
- Create customer response letters upon request
- Provide peer review and feedback of complaints and reports
- Participate in new hire training and continuous Regulatory Compliance training as required
- Participate in process improvement activities to continuously improve process effectiveness
Qualifications :
Required Skills and Experience
The following skills are required for this position:
- Demonstrate strong written and verbal communication skills
- Strong computer skills (Excel Word PowerPoint database)
- Efficient independent worker with ability to focus
- Attention to detail
- Demonstrate cross functional communication skills in email and in person
- Excellent organizational and analytical skills
- Ability to handle and manage workload independently
- Prioritize numerous activities in a rapid paced environment
- Contribute to teamoriented tasks
- Strong analytical skills
- Strong interpersonal and decisionmaking skills
- Time flexibility due to collaboration with Teams in different time zone.
The following experience is required for this position:
- 4 years of experience with experience in the following areas:
- Working knowledge and understanding of Medical Device Complaint files and quality record documentation
- Working knowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements EU MIR requirements etc
Required Education and Training
Education: degree in engineering life science or equivalent.
Training/Competencies:
- Firm understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements.
- Firm understanding of quality records requirements and how they apply to complaint files.
- Familiarity with worldwide regulatory reporting requirements.
- Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.
Additional Information :
Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados y prohibimos cualquier tipo de discriminacin y acoso independientemente de su raza sexo condicin de embarazo orientacin sexual identidad de gnero origen nacional color edad religin condicin de veterano protegido o de discapacidad informacin gentica o cualquier otra condicin protegida por las leyes federales estatales o locales aplicables.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
