Regulatory Post Market Surveillance Analyst
Regulatory Post Market Surveillance Analyst
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Salary Not Disclosed
1 Vacancy
Job Description
Primary Function of Position
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 Regulatory Post Market Surveillance Supervisor or Manager.
Essential Job Duties This position has responsibility and authority for:
- Investigating complaints daily:
- 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 Malfunction MDR Reports as identified
- Escalate Adverse Event or Incident reports to Level IV Analysts as identified
- Evaluate documentation for completeness and consistency and assign additional actions as necessary to close the complaint file.
- 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 establish if there are any anomalies that maybe related to reported product failures.
- Escalate complaints to the Regulatory Post Market Surveillance Manager or Drive 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 support 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
- Execute on projects as required
- Perform other duties as directed
Qualifications :
Required Skills and Experience
The following skills are required for this position:
- Demonstrate proven written and verbal communication skills
- Effective computer skills (Excel Word PowerPoint database)
- Efficient autonomous worker with ability to focus
- Attention to detail
- Demonstrate cross functional communication skills in email and in person
- Excellent organizational and analytical skills
- Responsible to handle and manage workload autonomously
- Prioritize numerous activities in a rapid paced environment
- Contribute to team-oriented tasks
- Excellent interpersonal and decision-making skills
The following experience is required for this position:
- 4 years of experience in medical device field 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: Undergraduate 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 world-wide regulatory reporting requirements.
- Able to make conclusions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.
Working Conditions
This position requires the ability to complete most of the workday using a computer.
Additional Information :
Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.
Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
Mandatory Notices
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.
We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
