Regulatory Post Market Surveillance Analyst Job at The Mom Project
Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic-assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with the top medical professionals, they continue to develop new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world.
We are seeking a Regulatory Post Market Surveillance Analyst on a contract basis to support our Customer's business needs. This role is 100% remote.
What you’ll do:
Investigate customer complaints, make initial reporting decisions, file regulatory reports, and ensure completeness and consistency of complaint documentation
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 the 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 may be related to reported product failures
Escalate complaints to the Regulatory Post Market Surveillance Manager or Lead when new failure modes are encountered
Escalate complaints with potentially 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 on 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 projects as required
Perform other duties as directed
Must Haves:
4+ years of experience in the medical device field
Working knowledge and understanding with Medical Device Complaint files and quality record documentation
Working knowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.)
Demonstrate strong written and verbal communication skills
Strong computer skills (Excel, Word, PowerPoint, database)
Efficient independent worker with the 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 team-oriented tasks
Strong analytical skills
Strong interpersonal and decision-making skills
Education:
Bachelor’s degree in degree in Engineering, Life Science, or equivalent preferred.
Hours & Location:
M-F, 40 hours/week. This role will be 100% remote.
All applicants applying for U.S. job openings must be legally authorized to work in the United States and are required to have US residency at the time of application.
Perks are available through our 3rd Party Employer of Record (Available upon completion of the waiting period for eligible engagements)
Health Benefits: Medical, Dental, Vision, Life (including spouse & child), 401k, STD/LTD, AD&D, and Commuter Benefits program.
The salary range for this position is $38.13 - $41.05 per hour.
Please Note :
ajayjain.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, ajayjain.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.
We are seeking a Regulatory Post Market Surveillance Analyst on a contract basis to support our Customer's business needs. This role is 100% remote.
What you’ll do:
Investigate customer complaints, make initial reporting decisions, file regulatory reports, and ensure completeness and consistency of complaint documentation
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 the 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 may be related to reported product failures
Escalate complaints to the Regulatory Post Market Surveillance Manager or Lead when new failure modes are encountered
Escalate complaints with potentially 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 on 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 projects as required
Perform other duties as directed
Must Haves:
4+ years of experience in the medical device field
Working knowledge and understanding with Medical Device Complaint files and quality record documentation
Working knowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.)
Demonstrate strong written and verbal communication skills
Strong computer skills (Excel, Word, PowerPoint, database)
Efficient independent worker with the 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 team-oriented tasks
Strong analytical skills
Strong interpersonal and decision-making skills
Education:
Bachelor’s degree in degree in Engineering, Life Science, or equivalent preferred.
Hours & Location:
M-F, 40 hours/week. This role will be 100% remote.
All applicants applying for U.S. job openings must be legally authorized to work in the United States and are required to have US residency at the time of application.
Perks are available through our 3rd Party Employer of Record (Available upon completion of the waiting period for eligible engagements)
Health Benefits: Medical, Dental, Vision, Life (including spouse & child), 401k, STD/LTD, AD&D, and Commuter Benefits program.
The salary range for this position is $38.13 - $41.05 per hour.
Please Note :
ajayjain.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, ajayjain.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.